Trial under ind

An original IND application submission lacking a clinical protocol is considered incomplete. Protocols for subsequent studies not submitted with the original IND application can be submitted at a later time as Protocol Amendments. When submitting a new clinical protocol as part of an IND application, consider the following:. Early developmental protocols should specify in detail all the elements of the study that are critical to safety.

Such elements may include all clinical safety assessments, toxicity monitoring, description of toxicity-based stopping rules, dose adjustment rules for individual patients and the overall trial, and adverse event recording and reporting;. B Defenses: Form of denials. If in good faith the pleader intends to deny all the averments in the preceding pleading, he may do so by general denial subject to the provisions of Rule If he does not intend a general denial, he may:.

If he lacks knowledge or information sufficient to form a belief as to the truth of an averment, he shall so state and his statement shall be considered a denial. If in good faith a pleader intends to deny only a part or a qualification of an averment, he shall specify so much of it as is true and material and deny the remainder. All denials shall fairly meet the substance of the averments denied. This rule shall have no application to uncontested actions for divorce, or to answers required to be filed by clerks or guardians ad litem.

C Affirmative defenses. A responsive pleading shall set forth affirmatively and carry the burden of proving: accord and satisfaction, arbitration and award, discharge in bankruptcy, duress, estoppel, failure of consideration, fraud, illegality, injury by fellow servant, laches, license, payment, release, res judicata, statute of frauds, statute of limitations, waiver, lack of jurisdiction over the subject-matter, lack of jurisdiction over the person, improper venue, insufficiency of process or service of process, the same action pending in another state court of this state, and any other matter constituting an avoidance, matter of abatement, or affirmative defense.

A party required to affirmatively plead any matters, including matters formerly required to be pleaded affirmatively by reply, shall have the burden of proving such matters. The burden of proof imposed by this or any other provision of these rules is subject to the rules of evidence or any statute fixing a different rule.

If the pleading mistakenly designates a defense as a counterclaim or a counterclaim as a defense, the court shall treat the pleading as if there had been a proper designation. D Effect of failure to deny. Averments in a pleading to which a responsive pleading is required, except those pertaining to amount of damages, are admitted when not denied in the responsive pleading.

Averments in a pleading to which no responsive pleading is required or permitted shall be taken as denied or avoided. E All pleadings to be concise and direct--Consistency. No technical forms of pleading or motions are required. All fictions in pleading are abolished.

When two [2] or more statements are made in the alternative and one [1] of them if made independently would be sufficient, the pleading is not made insufficient by the insufficiency of one or more of the alternative statements. A pleading may also state as many separate claims or defenses as the pleader has regardless of consistency and whether based on legal or equitable grounds.

All statements shall be made subject to the obligations set forth in Rule All motions and pleadings of any kind addressed to two [2] or more paragraphs of any pleading, or filed by two [2] or more parties, shall be taken and construed as joint, separate, and several motions or pleadings to each of such paragraphs and by and against each of such parties. All motions or pleadings containing two [2] or more subject-matters shall be taken and construed as separate and several as to each subject-matter.

All objections to rulings made by two [2] or more parties shall be taken and construed as the joint, separate, and several objections of each of such parties. A complaint filed by or against two [2] or more plaintiffs shall be taken and construed as joint, separate, and several as to each of said plaintiffs. F Construction of pleadings.

All pleadings shall be so construed as to do substantial justice, lead to disposition on the merits, and avoid litigation of procedural points. Pleading special matters. A Capacity. It is not necessary to aver the capacity of a party to sue or be sued, the authority of a party to sue or be sued in a representative capacity, or the legal existence of an organization that is made a party.

The burden of proving lack of such capacity, authority, or legal existence shall be upon the person asserting lack of it, and shall be pleaded as an affirmative defense. B Fraud, mistake, condition of the mind. In all averments of fraud or mistake, the circumstances constituting fraud or mistake shall be specifically averred. Malice, intent, knowledge, and other conditions of mind may be averred generally. C Conditions precedent.

In pleading the performance or occurrence of promissory or non-promissory conditions precedent, it is sufficient to aver generally that all conditions precedent have been performed, have occurred, or have been excused.

A denial of performance or occurrence shall be made specifically and with particularity, and a denial of excuse generally. D Official document or act. In pleading an official document or official act it is sufficient to aver that the document was issued or the act done in compliance with law. E Judgment. In pleading a judgment or decision of a domestic or foreign court, judicial or quasi-judicial tribunal, or of a board or officer, it is sufficient to aver the judgment or decision without setting forth matter showing jurisdiction to render it.

F Time and place. For the purpose of testing the sufficiency of a pleading, averments of time and place are material and shall be considered like all other averments of material matter. However, time and place need be stated only with such specificity as will enable the opposing party to prepare his defense.

G Special damages--Damages where no answer. When items of special damage are claimed, they shall be specifically stated. The relief granted to the plaintiff, if there be no answer, cannot exceed the relief demanded in his complaint; but, in any other case, the court may grant him any relief consistent with the facts or matters pleaded.

Pleading and proof of contributory negligence, assumed risk, res ipsa loquitur, consideration, bona fide purchaser, matters of judicial notice--Answer of distraint. A Defense of contributory negligence or assumed risk. In all claims alleging negligence, the burden of pleading and proving contributory negligence, assumption of risk, or incurred risk shall be upon the defendant who may plead such by denial of the allegation.

B Res ipsa loquitur. Res ipsa loquitur or a similar doctrine may be pleaded by alleging generally that the facts connected with the action are unknown to the pleader and are within the knowledge of the opposing party. C Consideration. When an action or defense is founded upon a written contract or release, lack of consideration for the promise or release is an affirmative defense, and the party asserting lack of it carries the burden of proof.

D Bona fide purchaser. When the rights of a person depend upon his status as a bona fide purchaser for value or upon similar requirements, such status must be pleaded and proved by the person asserting it, but it may be pleaded in general terms.

Once it is established that the person has given any required value, unless such value is commercially unreasonable, and that he has met any requirements of recordation, filing, possession, or perfection, the trier of fact must find that such value was given or such perfection was made in accordance with any requirements of good faith, lack of knowledge, or lack of notice unless and until evidence is introduced which would support a finding of its non-existence.

E Presumption--Matters of judicial notice. Neither presumptions of law nor matters of which judicial notice may be taken need be stated in a pleading. F Property distrained--Sufficient answer.

In an action to recover the possession of property distrained while doing damage, an answer that the defendant, or person by whose command he acted, was lawfully possessed of the real property upon which the distress was made, and that the property distrained was at the time doing damage thereon, shall be good without setting forth the title of such real property.

Pleading and proof of written instruments. A When instrument or copy, or an Affidavit of Debt shall be filed. When any pleading allowed by these rules is founded on a written instrument, the original, or a copy thereof, shall be included in or filed with the pleading. Such instrument, whether copied in the pleadings or not, shall be taken as part of the record. If a claim is based on credit card or other debt and no such signed writing evidencing the original debt ever existed, then copies of documents generated when the debt was incurred or the credit card was actually used shall be attached; and.

B Proof of execution of instruments filed with pleadings. When a pleading is founded on a written instrument and the instrument or a copy thereof is included in or filed with the pleading, execution of such instrument, indorsement, or assignment shall be deemed to be established and the instrument, if otherwise admissible, shall be deemed admitted into evidence in the action without proving its execution unless execution be denied under oath in the responsive pleading or by an affidavit filed therewith.

A denial asserting that another person who is not a party did execute the instrument, indorsement, or assignment may be made without such oath or affidavit only if the pleader alleges under oath or in an accompanying affidavit that after the exercise of reasonable diligence he was unable to make such person or his representative subdivision H a party, the reason therefor, and that he is without information as to such execution.

C Oath or affidavit of denial of execution must be made upon personal knowledge. An oath or affidavit denying execution as required and made under subdivision B of this rule shall be made upon the personal knowledge of the person making it, and, if general in form Rule 11 B , shall be deemed to be made upon such personal knowledge.

D Burden of proving execution. The ultimate burden of proving the execution of a written instrument is upon the party claiming its validity, but execution is presumed.

E Inspection of the original instrument. When a copy of a written instrument is filed with or copied in the pleadings under the provisions of this rule, the pleader shall permit inspection of the original unless it is alleged that the original is lost, whether by destruction, theft or otherwise, or unless it is alleged or established that the instrument is in the possession of another person and out of the control of the pleader or that the duty to allow inspection is otherwise excused.

The pleader shall allow inspection promptly upon request of a party, and inspection may be ordered by the court upon motion without a hearing at any time. A party failing to comply with such request or such order shall be subject to the provisions of Rule 37 B.

F Effect of non-compliance--Amendments. Non-compliance with the provisions of this rule requiring a written instrument or an Affidavit of Debt to be included with the pleading may be raised by the first responsive pleading or prior motion of a party. The court, in its sound discretion, may order compliance, the reasons for non-compliance to be added to the pleadings, or allow the action to continue without further pleading.

Amendments to correct the omission of a required written instrument, an assignment or indorsement thereof, the omission of a denial of the execution of a written instrument as permitted or required by this rule, or an Affidavit of Debt shall be governed by Rule 15, except as provided by subdivision A of this rule.

G Exceptions--Infants, incompetents, dead and insolvent persons. The requirement of this rule that execution of a written instrument be denied under oath or otherwise, shall not apply against a party who is not required to file a responsive pleading, or against a party who, at the time the responsive pleading is due or before the pleadings are closed, is or becomes dead, an infant or adjudicated incompetent or is the representative of such person or of a person who is dead, an infant, an adjudicated incompetent, or in insolvency proceedings.

Such parties shall be deemed to have denied execution or admissibility without any responsive pleading or denial. The presumption of execution as provided in subdivision D of this rule shall not apply to establish execution of a written instrument by a person who, at the time proof is required, is dead, an infant or adjudicated incompetent.

Form of pleading. A Caption--Names of parties. Every pleading shall contain a caption setting forth the name of the court, the title of the action, the file number, and a designation as in Rule 7 A. In the complaint the title of the action shall include the names of all the parties, but in other pleadings it is sufficient to state the name of the first party on each side with an appropriate indication of other parties.

B Paragraphs--Separate statements. All averments of a claim or defense shall be made in numbered paragraphs, the contents of each of which shall be limited as far as practicable to a statement of a single set of circumstances, and a paragraph may be referred to by number in all succeeding pleadings. Each claim founded upon a separate transaction or occurrence and each defense other than denials may be stated in a separate count or defense whenever a separation facilitates the clear presentation of the matters set forth.

C Adoption by reference--Exhibits. Statements in a pleading may be adopted by reference in a different part of the same pleading or in another pleading or in any motion. A copy of any written instrument which is an exhibit to a pleading is a part thereof for all purposes.

Signing and verification of pleadings. A Parties Represented by Attorney. Every pleading or motion of a party represented by an attorney shall be signed by at least one [1] attorney of record in his individual name, whose address, telephone number, and attorney number shall be stated, except that this provision shall not apply to pleadings and motions made and transcribed at the trial or a hearing before the judge and received by him in such form.

A party who is not represented by an attorney shall sign his pleading and state his address. Except when specifically required by rule, pleadings or motions need not be verified or accompanied by affidavit. The rule in equity that the averments of an answer under oath must be overcome by the testimony of two [2] witnesses or of one [1] witness sustained by corroborating circumstances is abolished.

The signature of an attorney constitutes a certificate by him that he has read the pleadings; that to the best of his knowledge, information, and belief, there is good ground to support it; and that it is not interposed for delay.

If a pleading or motion is not signed or is signed with intent to defeat the purpose of the rule, it may be stricken as sham and false and the action may proceed as though the pleading had not been served. For a willful violation of this rule an attorney may be subjected to appropriate disciplinary action.

Similar action may be taken if scandalous or indecent matter is inserted. B Verification by affirmation or representation. When in connection with any civil or special statutory proceeding it is required that any pleading, motion, petition, supporting affidavit, or other document of any kind, be verified, or that an oath be taken, it shall be sufficient if the subscriber simply affirms the truth of the matter to be verified by an affirmation or representation in substantially the following language:.

Any person who falsifies an affirmation or representation of fact shall be subject to the same penalties as are prescribed by law for the making of a false affidavit. C Verified pleadings, motions, and affidavits as evidence. When such pleadings, motions and affidavits are verified or under oath they shall not require other or greater proof on the part of the adverse party than if not verified or not under oath unless expressly provided otherwise by these rules, statute or other law.

Affidavits upon motions for summary judgment under Rule 56 and in denial of execution under Rule 9. Defenses and objections -- When and how presented -- By pleading or motion -- Motion for judgment on the pleadings. A When presented. The time allowed for the presentation of defenses and objections in a motion or responsive pleading shall be computed pursuant to the provisions of Rule 6 C.

B How presented. Every defense, in law or fact, to a claim for relief in any pleading, whether a claim, counterclaim, cross-claim, or third-party claim, shall be asserted in the responsive pleading thereto if one is required; except that at the option of the pleader, the following defenses may be made by motion:. The disposition of this motion shall be consistent with Trial Rule 75,. A motion making any of these defenses shall be made before pleading if a further pleading is permitted or within twenty [20] days after service of the prior pleading if none is required.

If a pleading sets forth a claim for relief to which the adverse party is not required to serve a responsive pleading, any of the defenses in section B 2 , 3 , 4 , 5 or 8 is waived to the extent constitutionally permissible unless made in a motion within twenty [20] days after service of the prior pleading.

No defense or objection is waived by being joined with one or more other defenses or objections in a responsive pleading or motion. If, on a motion, asserting the defense number 6 , to dismiss for failure of the pleading to state a claim upon which relief can be granted, matters outside the pleading are presented to and not excluded by the court, the motion shall be treated as one for summary judgment and disposed of as provided in Rule In such case, all parties shall be given reasonable opportunity to present all material made pertinent to such a motion by Rule C Motion for judgment on the pleadings.

After the pleadings are closed but within such time as not to delay the trial, any party may move for judgment on the pleadings. If, on a motion for judgment on the pleadings, matters outside the pleadings are presented to and not excluded by the court, the motion shall be treated as one for summary judgment and disposed of as provided in Rule 56, and all parties shall be given reasonable opportunity to present all material made pertinent to such a motion by Rule D Preliminary determination.

Whether made in a pleading or by motion, the defenses specifically enumerated 1 to 8 in subdivision B of this rule, and the motion for judgment on the pleadings mentioned in subdivision C of this rule shall, upon application of any party or by order of court, be determined before trial unless substantial justice requires the court to defer hearing until trial.

E Motion for more definite statement. If a pleading to which a responsive pleading is permitted is so vague or ambiguous that a party cannot reasonably be required to frame a responsive pleading, he may move for a more definite statement before interposing his responsive pleading.

The motion shall point out the defects complained of and the details desired. If the motion is granted and the order of the court is not obeyed within twenty [20] days after notice of the order or within such other time as the court may fix, the court may strike the pleading to which the motion was directed or make such order as it deems just. F Motion to strike. G Consolidation of defenses in motion.

A party who makes a motion under this rule may join with it any other motions herein provided for and then available to him. If a party makes a motion under this rule but omits therefrom any defense or objection then available to him which this rule permits to be raised by motion, he shall not thereafter make a motion based on the defense or objection so omitted.

He may, however, make such motions as are allowed under subdivision H 2 of this rule. H Waiver or preservation of certain defenses. Counterclaim and cross-claim. A Compulsory counterclaims. But the pleader need not state the claim if:. B Permissive counterclaims. C Counterclaim exceeding opposing claim. A counterclaim may or may not diminish or defeat the recovery sought by the opposing party.

It may claim relief exceeding in amount or different in kind from that sought in the pleading of the opposing party. D Counterclaim against state. This rule shall not be construed to enlarge any right to assert a claim against the state. E Counterclaim maturing or acquired after pleading.

A claim which either matured or was acquired by the pleader after serving his pleading may, with the permission of the court, be presented as a counterclaim by supplemental pleading. F Omitted counterclaim. When a pleader fails to set up a counterclaim through oversight, inadvertence, or excusable neglect, or when justice requires, he may by leave of court set up the counterclaim by amendment. G Cross-claim against co-party.

A pleading may state as a cross-claim any claim by one party against a co-party. H Joinder of additional parties. Persons other than those made parties to the original action may be made parties to a counterclaim or cross-claim in accordance with the provisions of Rules 14, 19 and I Separate trials--Separate judgments. If the court orders separate trials as provided in Rule 42 B , judgment on a counterclaim or cross-claim may be rendered in accordance with the terms of Rule 54 B when the court has jurisdiction so to do, even if the claims of the opposing party have been dismissed or otherwise disposed of.

In determining whether or not separate trial of a cross-claim shall be ordered, the court shall consider whether the cross-claim:. In addition, the court may consider any other relevant factors. J Effect of statute of limitations and other discharges at law.

The statute of limitations, a nonclaim statute or other discharge at law shall not bar a claim asserted as a counterclaim to the extent that:. K Counterclaim by and against transferees and successors. A counterclaim may be asserted by or against the transferee or successor of a claim subject to the following provisions:. A claim owing by his predecessor may be interposed against any claim brought by such successor in or outside the court of administration without the necessity of filing such claim or cause of action in the administration proceedings.

L Counterclaim and cross-claim subject to substantive law principles. Counterclaim and cross-claims are subject to restrictions imposed by other statutes and principles of substantive common law and equity, including rules of commercial law, agency, estoppel, contract and the like. In appropriate cases the court may impose terms or conditions upon its judgment or decree and may enter conditional or noncanceling cross judgments to satisfy such restrictions.

This provision is intended to deny or limit counterclaims or cross-claims:. M Satisfaction of judgment. Satisfaction of a judgment or credits thereon may be ordered, for sufficient cause, upon notice and motion.

Third-party practice. A When defendant may bring in third party. The third-party plaintiff must file the third-party complaint with his original answer or by leave of court thereafter with good cause shown. The person served with the summons and the third-party complaint, hereinafter called the third-party defendant, as provided in Rules 12 and 13 may make:. The plaintiff may assert any claim against the third-party defendant who thereupon may assert his defenses, counterclaims and cross-claims, as provided in Rules 12 and A third-party defendant may proceed under this rule against any person not a party to the action who is or may be liable to him for all or part of the claim made in the action against the third-party defendant.

B When plaintiff may bring in third party. When a counterclaim or other claim is asserted against a plaintiff, he may cause a third party to be brought in under circumstances, which, under this rule, would entitle a defendant to do so.

C Severance--Parties improperly impleaded. With his responsive pleading or by motion prior thereto, any party may move for severance of a third-party claim or ensuing claim as provided in this rule or for a separate trial thereon. If the third-party defendant is a proper party to the proceedings under any other rule relating to parties, the action shall continue as in other cases where he is made a party. Amended and supplemental pleadings. A Amendments. A party may amend his pleading once as a matter of course at any time before a responsive pleading is served or, if the pleading is one to which no responsive pleading is permitted, and the action has not been placed upon the trial calendar, he may so amend it at any time within thirty [30] days after it is served.

Otherwise a party may amend his pleading only by leave of court or by written consent of the adverse party; and leave shall be given when justice so requires.

A party shall plead in response to an amended pleading within the time remaining for response to the original pleading or within twenty [20] days after service of the amended pleading, whichever period may be the longer, unless the court otherwise orders.

B Amendments to conform to the evidence. When issues not raised by the pleadings are tried by express or implied consent of the parties, they shall be treated in all respects as if they had been raised in the pleadings.

Such amendment of the pleadings as may be necessary to cause them to conform to the evidence and to raise these issues may be made upon motion of any party at any time, even after judgment, but failure so to amend does not affect the result of the trial of these issues. If evidence is objected to at the trial on the ground that it is not within the issues made by the pleadings, the court may allow the pleadings to be amended and shall do so freely when the presentation of the merits of the action will be subserved thereby and the objecting party fails to satisfy the court that the admission of such evidence would prejudice him in maintaining his action or defense upon the merits.

The court may grant a continuance to enable the objecting party to meet such evidence. C Relation back of amendments. Whenever the claim or defense asserted in the amended pleading arose out of the conduct, transaction, or occurrence set forth or attempted to be set forth in the original pleading, the amendment relates back to the date of the original pleading.

An amendment changing the party against whom a claim is asserted relates back if the foregoing provision is satisfied and, within one hundred and twenty days of commencement of the action, the party to be brought in by amendment:. The requirement of subsections 1 and 2 hereof with respect to a governmental organization to be brought into the action as defendant is satisfied:. D Supplemental pleadings. Upon motion of a party the court may, upon reasonable notice and upon such terms as are just, permit him to serve a supplemental pleading setting forth transactions or occurrences or events which have happened since the date of the pleading sought to be supplemented.

Permission may be granted even though the original pleading is defective in its statement of a claim for relief or defense. If the court deems it advisable that the adverse party plead to the supplemental pleading, it shall so order, specifying the time therefor. Pre-trial procedure: Formulating issues. A When required--Purpose. In any action except criminal cases, the court may in its discretion and shall upon the motion of any party, direct the attorneys for the parties to appear before it for a conference to consider:.

B When called--Notice--Participants. Unless otherwise ordered by the court the pre-trial conference shall not be called until after reasonable opportunity for the completion of discovery.

At least one [1] attorney planning to take part in the trial shall appear for each of the parties and participate in the pre-trial conference. C Conference of attorneys. Unless otherwise ordered by the court, at least ten [10] days prior to the pre-trial conference, attorneys for each of the parties shall meet and confer for the following purposes:.

Each attorney shall mark for identification and provide opposing counsel an opportunity to inspect and copy all exhibits which he expects to introduce at the trial.

Exhibits of the character which prohibit or make impracticable their production at conference shall be identified and notice given of their intended use. Necessary arrangements must be made to afford opposing counsel an opportunity to examine such exhibits. Written stipulations shall be prepared with reference to all exhibits exchanged or identified.

The stipulations shall contain all agreements of the parties with reference to the exchanged and identified exhibits, and shall include, but not be limited to, the agreement of the parties with reference to the authenticity of the exhibits, their admissibility in evidence, their use in opening statements, and the provisions made for the inspection of identified exhibits. The original of the exhibit stipulations shall be presented to the court at the pre-trial conference.

The attorneys shall stipulate in writing with reference to all facts and issues not in genuine dispute. The original of the stipulations shall be presented to the court at the time of the pre-trial conference. Attorneys for each of the parties shall furnish opposing counsel with the written list of the names and addresses of all witnesses then known.

The original of each witness list shall be presented to the court at the time of the pre-trial conference. The possibility of compromise settlement shall be fully discussed and explored. D Preparation for conference of attorneys and pre-trial. Each attorney shall completely familiarize himself with all aspects of the case in advance of the conference of attorneys and be prepared to enter into stipulations with reference to as many facts and issues and exhibits as possible.

E Duty to arrange conference. It shall be the duty of counsel for both plaintiff and defendant to arrange for the conference of attorneys at least ten [10] days in advance of the pre-trial conference. F Refusal to stipulate. If, following the conference of attorneys, either party determines that there are other facts or exhibits that should be stipulated and which opposing counsel refuses to stipulate upon, he shall compile a list of such facts or exhibits and furnish same to opposing counsel at least two [2] days in advance of the pre-trial conference.

The original of the list shall be presented to the court at the time of the pre-trial conference. G Witnesses or exhibits discovered subsequent to conference of attorneys and before a pre-trial conference. If, after the conference of the attorneys and before the pre-trial conference, counsel discovers additional exhibits or names of additional witnesses, the same information required to be disclosed at the conference of the attorneys shall be immediately furnished opposing counsel. The original of any such disclosures shall be presented to the court at the time of the pre-trial conference.

H More than one pre-trial conference. If necessary or advisable, the court may adjourn the pre-trial conference from time to time or may order an additional pre-trial conference. I Witnesses or exhibits discovered subsequent to pre-trial conference. If, following the pre-trial conference or during trial, counsel discovers additional exhibits or the names of additional witnesses, the same information required to be disclosed at the conference between attorneys shall be immediately furnished opposing counsel.

The original of any such disclosure shall immediately be filed with the court and shall indicate the date it was furnished opposing counsel.

J Pre-trial order. The court shall make an order which recites the action taken at the conference, the amendments allowed to the pleading, and the agreements made by the parties as to any of the matters considered which limit the issues for trial to those not disposed of by admissions or agreement of counsel, and such order when entered shall control the subsequent course of action, unless modified thereafter to prevent manifest injustice. The court in its discretion may establish by rule a pre-trial calendar on which actions may be placed for consideration as above provided, and may either confine the calendar to jury actions or non-jury actions or extend it to all actions.

K Sanctions: Failure to appear. If without just excuse or because of failure to give reasonable attention to the matter, no appearance is made on behalf of a party at a pre-trial conference, or if an attorney is grossly unprepared to participate in the conference, the court may order either one or both of the following:.

Parties plaintiff and defendant--Capacity. A Real party in interest. Every action shall be prosecuted in the name of the real party in interest. No action shall be dismissed on the ground that it is not prosecuted in the name of the real party in interest until a reasonable time after objection has been allowed for the real party in interest to ratify the action, or to be joined or substituted in the action.

Such ratification, joinder, or substitution shall have the same effect as if the action had been commenced initially in the name of the real party in interest. B Capacity to sue or be sued. The capacity of a party to sue or be sued shall be determined by the law of this state, including its conflicts rules, except that a partnership or unincorporated association may sue or be sued in its common name.

C Infants or incompetent persons--Unborn, unknown, and unlocated persons. An infant or incompetent person may sue or be sued in any action:.

The court, upon its own motion or upon the motion of any party, must notify and allow the representative named in subsection 3 of this subdivision, if he is known, to represent an infant or incompetent person, and be joined as an additional party in his representative capacity. If an infant or incompetent person is not represented, or is not adequately represented, the court shall appoint a guardian ad litem for him.

The court may, in its discretion, appoint a guardian ad litem or an attorney for persons who are institutionalized, who are not yet born or in being, who are unknown, who are known but cannot be located, or who are in such position that they cannot procure reasonable representation.

The court shall make such other orders as it deems proper for the protection of such parties or persons. Persons with claims against the estate of the ward or against the guardian of his estate as such may proceed under this rule or provisions applicable to guardianship proceedings. It shall not be necessary that the person for whom guardianship is sought shall be represented by a guardian ad litem in such proceedings.

Nothing herein shall affect the right of a guardian to sue or be sued in his personal capacity. A next friend or guardian under subsection C of this rule may be required by the court to furnish bond or additional bond and shall be subject to the rules applicable to guardians of the estate with respect to duties, terms of the bond required, accounting, compensation and termination.

D Sex, marital and parental status. For the purposes of suing or being sued there shall be no distinction between men and women or between men and women because of marital or parental status; provided, however, that this subdivision D shall not apply to actions in tort. E Partnerships and unincorporated associations. A partnership or an unincorporated association may sue or be sued in its common name.

A judgment by or against the partnership or unincorporated association shall bind the organization as if it were an entity. A money judgment against the partnership or unincorporated association shall not bind an individual partner or member unless he is named as a party or is bound as a member of a class in an appropriate action Rules 23 and F Unknown persons. When the name or existence of a person is unknown, he may be named as an unknown party, and when his true name is discovered his name may be inserted by amendment at any time.

Parties: State as party--Attorney general. If in any action or proceeding involving real property, instituted in any court of this state, it appears from the allegations of any pleading filed therein that the state of Indiana has, or claims to have a lien upon or an interest in such real estate, the state may be made a party defendant to the action, and shall be bound by any judgment or decree rendered thereon.

Service of summons shall be made upon the Attorney General as provided in Rule 4. It shall be the duty of the Attorney General, in person or by deputy to appear and defend such proceedings or suit, on behalf of the state of Indiana. The Attorney General may, in his discretion, designate the prosecuting attorney of the circuit in which such action is pending as his deputy for the purpose of defending such proceedings or suit on behalf of the state of Indiana.

After the prosecuting attorney enters his appearance as such deputy, pleadings under Rule 5 shall be served upon him for and on behalf of the Attorney General. The state may appeal from such judgment or decree, in like manner and under the same terms and conditions as other parties in like cases.

This rule is meant, without limitation, to apply to actions to foreclose a mortgage or other lien on real estate, to subject any real estate to sale, or to partition or quiet title to real estate.

Further, in any case in which the Attorney General represents the State of Indiana, the judge presiding in the case where such cause is pending, shall promptly notify the Attorney General by United States mail, addressed to his office in Indianapolis, Indiana, of any ruling made in such cause or of the fixing of a date for the trial thereof.

Joinder of claims and remedies. When a product is identified as a viable candidate for further development, the sponsor then focuses on collecting the data and information necessary to establish that the product will not expose humans to unreasonable risks when used in limited, early-stage clinical studies. FDA's role in the development of a new drug begins when the drug's sponsor usually the manufacturer or potential marketer , having screened the new molecule for pharmacological activity and acute toxicity potential in animals, wants to test its diagnostic or therapeutic potential in humans.

At that point, the molecule changes in legal status under the Federal Food, Drug, and Cosmetic Act and becomes a new drug subject to specific requirements of the drug regulatory system. An Investigator IND is submitted by a physician who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed.

A physician might submit a research IND to propose studying an unapproved drug, or an approved product for a new indication or in a new patient population. It is also used for patients who do not meet the criteria of an existing study protocol, or if an approved study protocol does not exist.

Treatment IND is submitted for experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions while the final clinical work is conducted and the FDA review takes place. Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk.

This web site is designed for individuals from pharmaceutical companies, government agencies, academic institutions, private organizations, or other organizations interested in bringing a new drug to market.

For specific information, click on a link to go directly to a section or web page. The following resources include the legal requirements of an IND application, assistance from CDER to help you meet those requirements, and internal IND review principles, policies and procedures. The review divisions are organized generally along therapeutic class. Guidance Documents for INDs. Guidance documents represent the Agency's current thinking on a particular subject.

They also establish policies intended to achieve consistency in the Agency's regulatory approach and establish inspection and enforcement procedures.