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Public Hearing: Development of Articles for Rare Diseases, June 29-30, 2010

Mon, 06/21/2010 - 9:35am
U.S. Food & Drug Administration

On Tuesday, June 29, 2010, and Wednesday, June 30, 2010, FDA's Office of Orphan Products Development will host a two-day public hearing and Webcast on the Development of Articles for Rare Diseases.

This public hearing is intended to gain from health care providers, academia, industry, patients, and other interested persons their perspectives on various aspects of the development of medical products for the diagnosis, treatment, or management of rare diseases. The input from this public hearing will help inform the work of FDAâ??s committee for rare diseases.

The Food and Drug Administration (FDA) is announcing a public hearing regarding the Agencyâ??s regulation of drugs, biological products, and devices (e.g., therapies and diagnostics) for the treatment, diagnosis and/or management of rare diseases. This public hearing is intended to gain from health care providers, academia, industry, patients, and other interested persons their perspectives on various aspects of the development of medical products for the diagnosis, treatment, or management of rare diseases. The input from this public hearing will help inform the work of FDAâ??s committee for rare diseases. To help solicit such information and views, FDA is seeking responses to specific questions.

Please note: Written or electronic comments will be accepted after the hearing until August 31, 2010. All comments should be identified with the docket number (FDAâ?"2010â?"Nâ?"0218).

Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane (Room 1061), Rockville, MD 20852.

Submit electronic comments to http://www.regulations.gov/.

Paras M. Patel

Food and Drug Administration

Office of the Commissioner

Office of Special Medical Programs

Office of Orphan Products Development

10903 New Hampshire Avenue (Bldg. WO32-5271)

Silver Spring, MD 20993-0002

Phone: 301-796-8660

Fax: 301-847-8621

E-mail: OPDAR@fda.hhs.gov

    

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