Written Recommendations for Investigations of Orphan Drugs

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Drugs for Human Use
  6. Orphan Drugs
  7. Written Recommendations for Investigations of Orphan Drugs

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Section
316.10

Content and format of a request for written recommendations.

Section
316.12

Providing written recommendations.

Section
316.14

Refusal to provide written recommendations.