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Back To Vidyya FDA To Hold Meeting On Regulation Of OTC Medications

Scientists, Professionals & Consumers Invited To Attend

The Food and Drug Administration will convene a public meeting on June 28 and 29, 2000 to discuss the agency's approach to regulating over-the-counter (OTC) drug products. The purpose of the hearing is to solicit information from, and the views of interested persons -- including scientists, professional groups, and consumers.

The meeting will be held at the Gaithersburg Holiday Inn, 2 Montgomery Village Ave., Gaithersburg, MD on Wednesday, June 28 and Thursday, June 29, from 8:30 a.m. to 4:30 p.m.

The hearing will focus on the regulation of OTC drug-products, which raises many complex public health issues. Drugs found appropriate for OTC sale have an increasingly vital role in the U.S. health care system. OTC medications provide consumers easy access to certain pharmaceuticals that consumers are able to use safely without the help of a health care practitioner.

To facilitate the discussion, the agency has developed a list of questions and issues related to the development and regulation of OTC drugs. Issues that are of interest to the agency include: Criteria to be considered for decisions on OTC availability

  • Classes of drug products that should or should not be made available OTC

  • Consumer understanding of benefits and risks of particular medications

  • The FDA's role in switching drugs to over-the-counter status.
  • Persons who wish to participate in the hearing must file a written notice of participation with the Dockets Management Branch, prior to May 10, 2000. The public should submit written notices of participation and comments by June 2, 2000 to:

    Dockets Management Branch (HFA-305)
    Food and Drug Administration
    5630 Fishers Lane, Rm. 1061
    Rockville, MD 20852

    OR

    FDADockets@oc.fda.gov

    OR

    Visit the Internet site at:   http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm.

    Written comments will be accepted after the hearing until August 25, 2000. The Notice of Public Meeting was published in the Federal Register of April 27, 2000.

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    Editor: Susan K. Boyer, RN
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