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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.
PDF Version [53KB PDF]
The Draft Guidance [303KB PDF]
The Draft Guidance [Microsoft Word]
Erratum [Microsoft Word]
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Computerized Systems Used in Clinical Trials". This document provides guidance about computerized systems that are used to create, modify, maintain, archive, retrieve, or transmit clinical data required to be maintained and/or submitted to the FDA. This draft guidance, when finalized, will supercede the guidance of the same name issued in April 1999. Written and electronic comments must be submitted to the Division of Dockets Management (Docket 2004N-0440) by January 3, 2005.. [Submit electronic comments.]
7/6/04--FDA publishes proposed rule entitled "Institutional Review Boards; Registration Requirements"
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. [Submit
electronic comments.]
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:
Guidance document [73KB PDF]
The Food and Drug Administration (FDA) is announcing the availability of three draft guidances for industry entitled "Premarketing Risk Assessment,"' "Development and Use of Risk Minimization Action Plans," and "Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment." All are dated May 2004. These draft guidances provide guidance to industry on risk management activities for drug products, including biological drug products, in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The draft guidances address, respectively, premarket risk assessment; the development, implementation, and evaluation of risk minimization action plans for drug products; and good pharmacovigilance practices and pharmacoepidemiologic assessment of observational data.
Submit written or electronic comments on the draft guidance and on the collection of information to the Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, Room 1061, Rockville, MD 20852, by July 6, 2004. [Submit electronic comments.]
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. [Submit electronic comments.]
FDA announces the availability of a draft guidance for industry that provides recommendations to sponsors holding INDs, NDAs and BLAs on what pharmacogenomic data to submit to the agency during the drug development process, and explains how the data will be used in regulatory decision making. [ Docket # 2003D-0497]. Submit written or electronic comments on the draft guidance and on the collection of information to the Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, Room 1061, Rockville, MD 20852, by January 5, 2004.
Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857 or the Office of Communication, Training and Manufacturers Asssistance (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448.
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. Page 36527 [FR Doc. 03-15341])
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.
1/2003: FDA publishes Draft Guidance for industry re: Estimating the Safe Starting Dose in Clinical Trials for Therapeutics in Adult Healthy Volunteers [Microsoft Word document]
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.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Collection of Race and Ethnicity Data in Clinical Trials for FDA Regulated Products.'' This draft guidance recommends a standardized approach for collecting race and ethnicity information in clinical trials conducted in the United States and abroad for certain FDA regulated products. The standardized approach being recommended was developed by the Office of Management and Budget (OMB).
Comments on this draft guidance submitted to Docket No. 02D-0018 are presently being reviewed within FDA.
6/19/02-- FDA publishes Proposed Rule entitled "Investigational New Drugs: Export Requirements for Unapproved New Drug Products" [61KB PDF]
Text version of Federal Register Proposed Rule
A proposed rule was published today in the Federal Register advising that FDA is proposing to amend its regulations on the exportation of investigational new drugs that would provide four (4) mechanisms for exporting investigational new drugs and simplify the existing requirements for exporting investigational new drugs.
Comments on this draft guidance submitted to Docket No. 00N-1663 are presently under review within FDA.
3/6/2002--FDA Publishes Advance Notice of Proposed Rulemaking entitled "Institutional Review Boards: Requiring Sponsors and Investigators to Inform IRBs of Any Prior IRB Reviews" [79KB PDF]
Text version of draft guidance
This advance notice of proposed rulemaking (ANPRM) identifies important issues
about which FDA would like further comment as it considers whether to amend
its institutional review board (IRB) regulations to require sponsors and investigators
to inform IRBs about any prior IRB review decisions. FDA invites public comments
to this ANPRM. These comments will help FDA decide whether a regulation is needed
and, if so, what the regulation's requirements should be.
[Announced in the Federal Register March 6, 2002]
11/20/2001--FDA Publishes Draft Guidance for Clinical Trial Sponsors on the Establishment and Operation of Data Monitoring Committees [79KB PDF]
Text version of draft guidance
FDA has published a draft guidance that discusses the roles, responsibilities, and operating procedures of Data Monitoring Committees (DMCs) that carry out important aspects of clinical trial monitoring. This document is intended to assist sponsors of clinical trials in determining when a DMC is needed for optimal study monitoring, and how such committees should operate. Many different models have been proposed and used for the operation of DMCs. The intent of this draft guidance is not to dictate the use of any particular approach but rather to ensure wide awareness of potential concerns that may arise in specific situations
An Open Public Meeting was held on Nov. 27, 2001. Comments on this draft guidance submitted to docket number 01D-0489 are presently under review within FDA.
In recent years, regulatory authorities and industry associations have undertaken many important initiatives to promote international harmonization of regulatory requirements. The International Conference on Harmonisation (ICH) was organized to provide an opportunity for tripartite harmonization initiatives to be developed with input from both regulatory and industry representatives. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products among three regions: The European Union, Japan, and the United States.
This draft guidance describes exceptions to the requirement to obtain informed
consent from each subject, or the subject's legally authorized representative,
prior to enrollment in a clinical investigation. The exception applies to emergency
research (1) for which an Investigational New Drug Application (IND) or Investigational
Device Exemption (IDE) is in effect, (2) involving human subjects who cannot
give informed consent because of their emerging, life-threatening medical condition
(for which available treatments are unproven or unsatisfactory), and (3) where
the intervention must be administered before informed consent from the subjects'
legally authorized representative is feasible.
[Released for comment March 30, 2000]
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