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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.
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
This draft guidance is intended to assist investigators in meeting their responsibilities with respect to protecting human subjects and ensuring the integrity of data in the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.
Federal Register Notice [Federal Register Notice in PDF format]
This guidance is intended to assist the research community in interpreting requirements for submitting reports of unanticipated problems, including certain adverse events reports, to the Institutional Review Board (IRB).
Submit comments on the draft guidance by June 8, 2007.
Federal Register Notice [PDF, 51KB]
The Food and Drug Administration (FDA) is announcing the availability of a draft document for the public, FDA advisory committee members, and FDA staff entitled "Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees" dated March 2007. This draft guidance describes the factors and analyses that should be used in considering whether an advisory committee member has a potential conflict of interest and whether participation in a meeting is appropriate.
Submit written or electronic comments on the draft guidance by May 21, 2007.
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.
Federal Register Notice [PDF version (1.3 MB)]
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Written or electronic comments on this draft guidance will be accepted until March 5, 2007.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.
Federal Register Notice in PDF format
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)
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.
Federal Register Notice [PDF]
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.
Federal Register notice [PDF, 406KB]
This draft guidance is intended to assist persons producing drug and biological products (investigational drugs) for use during phase 1 development in complying with the relevant current good manufacturing practices regulations.
PDF Version of Draft Guidance [104KB PDF]
The FDA is developing guidance on oncology endpoints through a process that includes public workshops of oncology experts and discussions before the FDA's Oncologic Drugs Advisory Committee (ODAC). This guidance is the first in a planned series of cancer endpoint guidances. It provides background information and discusses general regulatory principles. The endpoints discussed in this guidance document are for drugs to treat patients with an existing cancer.
Comments can be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852 (Docket 2005D-0112).
PDF version [77KB PDF]
Pre-publication document [1.87MB PDF]
The Food and Drug Administration (FDA) is proposing to require institutional
review boards (IRBs) to register at a site maintained by DHHS. The registration
information would include contact information, the number of active protocols
involving FDA-regulated products reviewed in the previous calendar year,
and a description of the types of FDA-regulated products involved in the
protocols reviewed. The proposed IRB registration requirement would make
it easier for FDA to inspect IRBs and to convey information to IRBs.
Comments on the proposed rule (Docket # 2004N-0242) must be submitted by
October 4, 2004.
PDF version [80KB PDF]
The Food and Drug Administration (FDA) is proposing to revise its regulations on its acceptance of foreign clinical studies not conducted under an investigational new drug application (IND) as support for an IND or marketing application for a drug or biological product. We are proposing to replace the requirement that such studies be conducted in accordance with ethical principles stated in the Declaration of Helsinki (Declaration) with a requirement that the studies be conducted in accordance with good clinical practice (GCP), including review and approval by an independent ethics committee (IEC). The proposed rule is intended to update the standards for the acceptance of nonIND foreign studies and to help ensure the quality and integrity of data obtained from such studies.
Submit written or electronic comments by September 8, 2004.You may submit comments, identified by Docket No. 2004N- 0018, by any of the following methods:
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.
PDF version of the announcement
PDF version of Federal Register Proposed Rule [667KB PDF]
Pre-Publication Federal Register [NOTE: This document] is over 475 pages (754K). If you use a modem, download before attempting to print.]
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 postmarketing 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 postmarketing 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.
FDA has published a draft guidance that outlines a process and vocabulary for deriving the maximum recommended starting dose (MRSD) for "first in human" clinical trials of new molecular entities in adult healthy volunteers and recommends a standardized process by which the MRSD can be selected. The purpose of this process is to ensure the safety of the human volunteers.
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