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- Compliance policy for certain compounding of oral oxitriptan (5-HTP) drug products for patients with tetrahydrobiopterin (BH4) deficiency: immediately in effect guidance for industry1
- Compounded drug products that are essentially copies of a commercially available drug product under Section 503A of the Federal Food, Drug, and Cosmetic Act1
- Compounded drug products that are essentially copies of approved drug products under Section 503B of the Federal Food, Drug, and Cosmetic Act1
- Compounding certain ibuprofen oral suspension products under section 503B of the Federal Food, Drug, and Cosmetic Act1
- E11(R1) addendum: clinical investigation of medicinal products in the pediatric population1
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