Getting Information About the FDA and Its Activities
www.fda.gov: FDA home page with consumer education material, press releases, industry guidance, bulletins for health professionals, and other information and data.
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:
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 Web site 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
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)
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.
This article was provided by The Center for AIDS. It is a part of the publication Research Initiative/Treatment Action!. Visit CFA's website to find out more about their activities and publications.