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Titles
- 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
- Facility definition under Section 503B of the Federal Food, Drug, and Cosmetic Act1
- Liposome drug products: chemistry, manufacturing, and controls : human pharmacokinetics and bioavailability : and labeling documentation1
- Most hospitals obtain compounded drugs from outsourcing facilities, which must meet FDA quality standards1
- Policy for temporary compounding of certain alcohol-based hand sanitizer products during the public health emergency: immediately in effect guidance for industry1
- Policy for testing of alcohol (ethanol) and isopropyl alcohol for methanol: guidance for industry1
- Q3C--tables and list1
- Questionable billing for compounded topical drugs in Medicare Part D1
- Temporary policy for preparation of certain alcohol-based hand sanitizer products during the public health emergency (COVID-19)1