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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:
The guidance document entitled "Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection," is for Institutional Review Boards (IRBs), investigators, research institutions, and other interested parties as announced in Federal Register, Vol. 69, No.92, May 12, 2004, Page 26393. It applies to all human subjects research conducted or supported by HHS agencies or regulated by the Food and Drug Administration.
For more information, read the HHS Press Release.
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "INDs for Phase 2 and Phase 3 Studies; Chemistry, Manufacturing, and Controls Information.'' This guidance is intended to provide recommendations to sponsors of investigational new drug applications (INDs) on the chemistry, manufacturing, and controls documentation (CMC), including microbiology documentation, that should be submitted for phase 2 and 3 studies conducted under INDs. The guidance applies to human drugs (as defined in the Federal Food, Drug, and Cosmetic Act). The guidance does not apply to botanical drug products, protein drugs derived from natural sources or produced by the use of biotechnology, or other biologics.
The HHS Office of Civil Rights issued a letter responding to a request for clarification of IRBs' responsibilities under Federal regulations and international guidelines for reviewing and approving stand-alone HIPAA authorizations.
The HHS Office of Civil Rights (OCR) is the Department's lead Office for providing guidance on the Health Insurance Portability and Accountability Act (HIPAA) and Standards for Privacy of Individually Identifiable Health Information (the Privacy Rule). OCR has provided extensive guidance and other technical assistance materials that clarify key provisions of the rule. The OCR Web site contains many of these materials, including an extensive collection of frequently asked questions. Additional information about HIPAA can also be found on the OCR Web site. These Web sites will continue to be updated as new guidance is made available.
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).
Written or electronic comments may be submitted to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852 (Docket No.02D-0018) through March 31, 2003
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 Assistance (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. Send two self-addressed adhesive labels to assist that office in processing your requests. [Submit Comments]
The "Investigational New Drug Application (IND)" Form FDA-1571 and the "Statement of Investigator" Form FDA-1572 found on the FDA Forms Distribution Page may be used until further notice. The OMB expiration date for these forms has been currently extended to Jan. 31, 2006.
(Note: This date refers to OMB's approval for FDA to collect information contained in these forms. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number).
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