Source: http://www.law.cornell.edu/cfr/text/21/312.2?quicktabs_7=0
Timestamp: 2014-08-23 00:14:16
Document Index: 304199270

Matched Legal Cases: ['art 312', '§ 312', 'art 56', 'art 50', '§ 312', '§ 312', '§ 312', '§ 50', '§ 320', 'art 314', 'art 312', 'art 312']

21 CFR 312.2 - Applicability. | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter D › Part 312 › Subpart A › Section 312.2 21 CFR 312.2 - Applicability.
§ 312.2
Except as provided in this section, this part applies to all clinical investigations of products that are subject to section 505 of the Federal Food, Drug, and Cosmetic Act or to the licensing provisions of the Public Health Service Act (58 Stat. 632, as amended (42 U.S.C. 201
et seq.)).
The clinical investigation of a drug product that is lawfully marketed in the United States is exempt from the requirements of this part if all the following apply:
The investigation is not intended to be reported to FDA as a well-controlled study in support of a new indication for use nor intended to be used to support any other significant change in the labeling for the drug;
If the drug that is undergoing investigation is lawfully marketed as a prescription drug product, the investigation is not intended to support a significant change in the advertising for the product;
The investigation does not involve a route of administration or dosage level or use in a patient population or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product;
The investigation is conducted in compliance with the requirements for institutional review set forth in part 56 and with the requirements for informed consent set forth in part 50; and
The investigation is conducted in compliance with the requirements of § 312.7.
A clinical investigation involving an in vitro diagnostic biological product listed in paragraph (b)(2)(ii) of this section is exempt from the requirements of this part if (a) it is intended to be used in a diagnostic procedure that confirms the diagnosis made by another, medically established, diagnostic product or procedure and (b) it is shipped in compliance with § 312.160.
In accordance with paragraph (b)(2)(i) of this section, the following products are exempt from the requirements of this part: (a) blood grouping serum; (b) reagent red blood cells; and (c) anti-human globulin.
A drug intended solely for tests in vitro or in laboratory research animals is exempt from the requirements of this part if shipped in accordance with § 312.160.
FDA will not accept an application for an investigation that is exempt under the provisions of paragraph (b)(1) of this section.
A clinical investigation involving use of a placebo is exempt from the requirements of this part if the investigation does not otherwise require submission of an IND.
A clinical investigation involving an exception from informed consent under § 50.24 of this chapter is not exempt from the requirements of this part.
Bioavailability studies.
The applicability of this part to in vivo bioavailability studies in humans is subject to the provisions of § 320.31.
Unlabeled indication.
This part does not apply to the use in the practice of medicine for an unlabeled indication of a new drug product approved under part 314 or of a licensed biological product.
FDA may, on its own initiative, issue guidance on the applicability of this part to particular investigational uses of drugs. On request, FDA will advise on the applicability of this part to a planned clinical investigation.
Title 21 published on 2013-04-01The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 312 after this date.2013-05-09; vol. 78 # 90 - Thursday, May 9, 201378 FR 27115 - Draft Guidance for Industry on Expanded Access to Investigational Drugs for Treatment Use—Questions and Answers; Availability
typeregulations.gov FR Doc.2013-11005 RIN Docket No.FDA-2013-D-0446 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notice of availability. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 8, 2013. 21 CFR Part 312 SummaryThe Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Expanded Access to Investigational Drugs for Treatment Use—Qs & As.” This guidance is intended to provide information for industry, researchers, physicians, and patients about certain aspects of FDA&apos;s implementation of its regulations on expanded access to investigational drugs for treatment use. FDA has received a number of questions about implementation of its expanded access regulations. Therefore, FDA is providing this draft guidance in a question and answer format, addressing the most frequently asked questions.
78 FR 27116 - Draft Guidance for Industry on Charging for Investigational Drugs Under an Investigational New Drug Application—Questions and Answers; Availability
typeregulations.gov FR Doc.2013-11006 RIN Docket No.FDA-2013-D-0447 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notice of availability. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 8, 2013. 21 CFR Part 312 SummaryThe Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Charging for Investigational Drugs Under an IND—Qs & As.” This guidance is intended to provide information for industry, researchers, and physicians on how FDA is implementing its regulation on charging for an investigational drug under an investigational new drug (IND) application. FDA has received a number of questions about how it is implementing the charging regulation. Therefore, FDA is providing this draft guidance in a question and answer format, addressing the most frequently asked questions and answers, including questions about charging for investigational drugs made available under expanded access programs.