Science & Research
Proposed Regulations and Draft Guidances
Draft regulations and guidances are documents that have been proposed, but FDA has not made a decision as to whether the proposal will be adopted in whole, in part, or not at all. Each FDA draft document lists how to submit comments to the agency concerning the draft.
The entries below are listed in order by publication date.
7/29/08: FDA announces the availability of the draft guidance entitled “Information Sheet Guidance for Sponsors, Clinical Investigators, and Institutional Review Boards on Frequently Asked Questions--Statement of Investigator (Form FDA 1572).
This guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of investigational drugs and biologics in completing the Statement of Investigator form (Form FDA 1572). Comments are due September 29, 2008
5/10/07: FDA is announcing the availability of a draft guidance for industry entitled "Protecting the Rights, Safety and Welfare of Study Subjects- Supervisory Responsibilities of Investigators."
This draft guidance is intended to assist investigators in meeting their responsibilities with respect to protecting human subjects and ensuring the integrity of data in the conduct of clinical investigations.
12/14/06: FDA is proposing to amend its regulations on access to investigational new drugs for the treatment of patients (PDF, 3.7 MB)
Under the proposed rule, expanded access to investigational drugs for treatment use would be available to individual patients, including emergencies; intermediate-size patient populations; and larger populations under a treatment protocol or treatment IND.
12/14/06: FDA is proposing to amend its IND regulation concerning charging patients for investigational drugs
The proposed rule is intended to permit charging for a broader range of investigational and expanded uses than is explicitly permitted in current regulations.
Federal Register Notice [PDF version (1.3 MB)]
Written or electronic comments on this draft guidance will be accepted until March 5, 2007. [Submit electronic comments.]
Federal Register Notice
Written or electronic comments on this draft guidance will be accepted until March 5, 2007. [Submit electronic comments.
8/29/06: FDA Announces the Availability of a Draft Guidance Titled "Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research [PDF]
Press Release (Aug. 29, 2006)
The Food and Drug Administration announces the availability of a draft guidance for IRBs, clinical investigators and sponsors on exception from informed consent requirements for emergency research (21 CFR 50.24). This draft guidance, when finalized, is intended to assist in the development and conduct of emergency research. It also describes the additional specific human subject protection requirements for emergency research.
Comments are due October 30, 2006. Submit electronic comments. (Docket No. 2006D-0331, OC 2006163)
2/3/06: The Food and Drug Administration (FDA) announces the availability of a draft guidance for industry entitled "Patient-Reported Outcome Measures: Usein Medical Product Development to Support Labeling Claims." [PDF,586 KB]
This document provides guidance to industry on the measurement of patient-reported outcomes (PROs) in studies to support medical product claims in approved labeling. The draft guidance describes how FDA evaluates PRO instruments used as effectiveness endpoints in clinical trials. It also describes our current thinking on how sponsors can develop and use PRO instruments to support claims in approved product labeling.
1/17/06: Withdrawal of the Advance Notice of Proposed Rulemaking entitled "Institutional Review Boards: Requiring Sponsors and Investigators to Inform InstitutionalReview Boards of Any Prior Institutional Review Boards Reviews"
After reviewing public comments on this ANPRM, FDA concluded that rulemaking on this matter was not warranted at this time. A notice withdrawing this ANPRM published in the Federal Register on Jan. 16, 2006. This notice can be found on FDA's Dockets Management Web site at www.accessdata.fda.gov/scripts/oc/ohrms/frbydocket.cfm.
The effective date for this withdrawal is February 16, 2006.
PDF version of the draft guidance
FDA is revising its March 2002 guidance for industry of the same title to include guidance for sponsors who will be submitting information required by the Best Pharmaceuticals for Children Act. Written comments should be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Electronic comments for Docket No. 2004D-0014 must be submitted by March 29, 2004.
6/18/03--FDA announces an extension until October 14, 2003, of the comment period for the proposed rule to amend the Agency's pre-and post marketing safety reporting requirements for human drugs and biologics. [See 3/14/03 entry below.] (Docket No. 00N-1484, CDER 2003101. Safety Reporting Requirements for Human Drug and Biological Products; Extension of Comment Period. Page36527 [FR Doc. 03-15341])
Submit comments on Info collection by April 14, 2003 and all others by July 14, 2003.
The Food and Drug Administration (FDA) is proposing to amend its pre- and post marketing safety reporting regulations for human drug and biological products to implement definitions and reporting formats and standards recommended by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and by the World Health Organization's (WHO's) Council for International Organizations of Medical Sciences (CIOMS); codify the agency's expectations for timely acquisition, evaluation, and submission of relevant safety information for marketed drugs and licensed biological products; require that certain information, such as domestic reports of medication errors, be submitted to the agency in an expedited manner; clarify certain requirements; and make other minor revisions. FDA is also proposing to amend its post marketing annual reporting regulations for human drug and licensed biological products by revising the content for these reports.
Comments on this draft guidance submitted to Docket No. 00N-1484 are presently being reviewed within FDA.