Sources of FDA Information for Health Professionals

The FDA has taken steps to optimize access to its information by health professionals and others who use, or would find it advantageous to use, that information. For example, the agency has greatly expanded the amount of information it makes available on the Internet and has established and publicized a number of agency telephone numbers for use by health professionals. Further, a number of its offices utilize a "fax-back" system whereby written materials are readily available by fax, and the MedWatch program has an electronic listserve and Internet site that provide drug safety information on an immediate basis. In view of the effectiveness of these mechanisms for providing a vast quantity of information in a more timely fashion, the agency has concluded that the usefulness of the FDA Medical Bulletin is greatly diminished and has decided to discontinue it in its present form. This is the final issue of the FDA Medical Bulletin as a separate, hard copy publication. Some of the major alternative sources of agency information for health professionals are outlined below:

FDA Homepage on the Internet:

http://www.fda.gov with numerous links. Examples include:

Under "Human Drugs" choice and then "Drug Information":

• FDA Drug Approval Packages:
  Typically includes the detailed reviews and recommendations of the scientists considering a drug's approval, as well as the final approved package insert and other materials.
• Consumer Drug Information:
  Information sheets on newly approved drugs for consumers.

Under "What's New" choice:

• Hot topics
• Press releases
• Upcoming meetings

Under "Medical Devices and Radiological Health" choice:

• Year 2000 information
• Program areas with link to safety alerts and advisories
• General information with link for telephone referrals

Under "Biologics" choice:

• Product Information with links to recall/withdrawal/safety issues, product approvals, information sheets.
• Publications information with links to memoranda to blood establishments, letters to healthcare providers, etc.

Under "Foods" choice, and then "Program Areas":

• Dietary Supplement information, including warnings on certain products.

Under "MedWatch," Medical Products Reporting choice:

• Safety information, including "Dear Health Professional" letters and labeling changes related to medical product safety
• Report adverse reactions and medical product problems to the FDA via the Internet

FDA Telephone Numbers: Product-Related Information

• Advisory Committee Information Line: 800-741-8138
  Up-to-date information about advisory committee meetings.
  
• Center for Drug Evaluation and Research, Drug Information Branch: 301-827-4573
  For information on human drug products.
  
• Center for Biologics Evaluation and Research, Office of Communication, Training and Manufacturers Assistance: 301-827-2000
  For information on biological products, including vaccines and blood.
  
• Center for Devices and Radiological Health, Consumer Information Service: 301-443-4190
  Automated request for information on devices and radiation-emitting products.
  
• Office of Orphan Products Development: 301-827-3666
  Information on products for rare diseases.
  
• General Inquiries: (888)-INFO-FDA

FDA Medical Product Reporting Program Telephone Numbers

• MedWatch (24-hour service): 800-332-1088
  Reporting of problems with drugs, devices, biologics
  (except vaccines), medical foods, dietary supplements, medication errors
  
• Vaccine Adverse Event Reporting (24-hour service): 800-822-7967
  Reporting of vaccine-related problems.
  

Telephone Numbers for Information Available by Fax

• Center for Drug Evaluation and Research Fax-on-Demand: 800-342-2722
• Center for Biologics Evaluation and Research Fax-on-Demand: 800-835-4709
• Center for Devices and Radiological Health Facts-on-Demand: 800-899-0381 or 301-827-0111

(Hypertext created by tg 1999-JUL-09)