21 CFR 312.55 - Informing investigators. | Title 21 - Food and Drugs | Code of Federal Regulations

§ 312.55

Informing investigators.

(a) Before the investigation begins, a sponsor (other than a sponsor-investigator) shall give each participating clinical investigator an investigator brochure containing the information described in § 312.23(a)(5).

(b) The sponsor shall, as the overall investigation proceeds, keep each participating investigator informed of new observations discovered by or reported to the sponsor on the drug, particularly with respect to adverse effects and safe use. Such information may be distributed to investigators by means of periodically revised investigator brochures, reprints or published studies, reports or letters to clinical investigators, or other appropriate means. Important safety information is required to be relayed to investigators in accordance with § 312.32.

[52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 67 FR 9586, Mar. 4, 2002]

Title 21 published on 2012-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

2012-04-30; vol. 77 # 83 - Monday, April 30, 2012

77 FR 25353 - Disqualification of a Clinical Investigator

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-10292
RIN	0910-AG49
Docket No.	FDA-2011-N-0079

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule.

This rule is effective May 30, 2012.

21 CFR Parts 16, 312, 511, and 812

Summary

The Food and Drug Administration (FDA) is amending the regulations to expand the scope of clinical investigator disqualification. Under this rulemaking, when the Commissioner of Food and Drugs (the Commissioner) determines that an investigator is ineligible to receive one kind of test article (drugs, devices or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for other kinds of products regulated by FDA. This final rule is based in part upon recommendations from the Government Accountability Office (GAO), and is intended to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA. FDA also is amending the list of regulatory provisions under which an informal regulatory hearing is available by changing the scope of certain provisions and adding regulatory provisions that were inadvertently omitted.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

United States Code

USC : Title 21 - FOOD AND DRUGS

§ 353 - Exemptions and consideration for certain drugs, devices, and biological products

§ 360bbb - Expanded access to unapproved therapies and diagnostics

Title 21 published on 2012-04-01

The 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, 2013

78 FR 27115 - Draft Guidance for Industry on Expanded Access to Investigational Drugs for Treatment Use—Questions and Answers; Availability

GPO FDSys XML | Text

Additional Documents

type	regulations.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

Summary

The 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'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

GPO FDSys XML | Text

Additional Documents

type	regulations.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

Summary

The 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.

2012-04-30; vol. 77 # 83 - Monday, April 30, 2012

77 FR 25353 - Disqualification of a Clinical Investigator

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-10292
RIN	0910-AG49
Docket No.	FDA-2011-N-0079

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule.

This rule is effective May 30, 2012.

21 CFR Parts 16, 312, 511, and 812

Summary

The Food and Drug Administration (FDA) is amending the regulations to expand the scope of clinical investigator disqualification. Under this rulemaking, when the Commissioner of Food and Drugs (the Commissioner) determines that an investigator is ineligible to receive one kind of test article (drugs, devices or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for other kinds of products regulated by FDA. This final rule is based in part upon recommendations from the Government Accountability Office (GAO), and is intended to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA. FDA also is amending the list of regulatory provisions under which an informal regulatory hearing is available by changing the scope of certain provisions and adding regulatory provisions that were inadvertently omitted.

21 CFR 312.55 - Informing investigators.

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