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U.S. Food and Drug Administration
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  3. Medical products for rare diseases and conditions
  4. Designating an Orphan Product: Drugs and Biological Products
  5. Orphan Drug Modernization Plan
  1. Designating an Orphan Product: Drugs and Biological Products

Orphan Drug Modernization Plan

On June 29, 2017 , the U.S. Food and Drug Administration unveiled a strategic plan to completely eliminate the agency’s existing orphan designation backlog and ensure continued timely response to all new requests for designation with firm deadlines. The agency’s Orphan Drug Modernization Plan comes a week after FDA Commissioner Scott Gottlieb committed to eliminating the backlog within 90 days and respond to all new applications within 90 days of receipt during his testimony before a Senate subcommittee.

 

 Searchable Databases

 Searchable database for Orphan Designated and or Approved Products. Note list will be updated monthly.

 

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