Getting information about the FDA and its activities. (FDA Contacts).
Office of Special Health Issues--a special office of the FDA that answers questions about the FDA's activities related to HIV/AIDS, cancer, the Patient Representative Program, and other special health issues. For assistance or information contact:
Richard Klein Food and Drug Administration Office of Special Health Issues 5600 Fishers Lane, F-12 Rockville, MD 20857 voice: 301.827.4460 fax: 301.443.4555 e-mail: Rklein@oc.fda.gov
list.nih.gov/archives/fda-hiv-aids.html--electronic service providing timely notice via e-mail of product approvals, significant labeling changes, safety warnings, notices of upcoming meetings, and alerts to proposed regulatory guidances for public comment.
Federal Register--a governmental publication issued daily (Monday through Friday), carrying all proposed and finalized regulations and significant legal notices. Notices of the FDA's public meetings and advisory committee meetings are published in the Federal Register. Each notice contains the date, time, and place of the meeting, as well as the agenda. The Federal Register is available through libraries in printed form or it may be accessed through the Internet at www.access.gpo.gov/su_docs/.
FDA News Page--a website that contains information about new FDA issues that are open for public comment at www.fda.gov/opacom/hpnews.html.
FDA Advisory Committee Information Line--800.741.8138 (or 301.443.0572 in the Washington, DC area). A 5-digit code is assigned to each advisory committee. Information for a particular advisory committee meeting can be obtained by dialing the 800 telephone number above and then the 5-digit code. Some pertinent advisory committee codes follow:
Biological Response Modifiers Advisory Committee--12389
Vaccine and Related Biological Products Advisory Committee--12391
Antiviral Drugs Advisory Committee--12531
Oncologic Drugs Advisory Committee--12542
888.INFO.FDA (888.463.6332)--toll-free general information and referral line.
800.TRIALS.A (800.874.2572)--toll-free number for information about current HIV/AIDS trials underway in the United States, provided by the AIDS Clinical Trials Information Service (ACTIS).
www.fda.gov/foi/foia2.htm--the FDA's Electronic Freedom of Information Reading Room.
For additional information or to make a Freedom of Information request in writing, contact: Freedom of Information Staff (HFI-35) FDA 5600 Fishers Lane Rockville, MD 20857 fax: 301.443.1726
Note: proprietary or confidential information cannot be obtained through a Freedom of Information request.
For guidance on how to comment on proposals and submit petitions to the FDA, consult "From Test Tube to Patient: Improving Health Through Human Drugs" (p. 96), which can be found on the Internet at www.fda.gov/cder/about/whatwedo/testtube.pdf.
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|Publication:||Research Initiative/Treatment Action!|
|Article Type:||Brief Article|
|Date:||Jun 22, 2002|
|Previous Article:||An overview of the drug approval process. (FDA Overview).|
|Next Article:||Accelerated approval: where are we now? (Viewpoint).|