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Titles
- Adaptive designs for clinical trials of drugs and biologics1
- Biological product deviation reporting for blood and plasma establishments1
- COVID-19 public health emergency: general considerations for pre-IND meeting requests for COVID-19 related drugs and biological products : guidance for industry and investigators1
- COVID-19: developing drugs and biological products for treatment or prevention1
- Clarification of orphan designation of drugs and biologics for pediatric subpopulations of common diseases1
- Considerations in demonstrating interchangeability with a reference product1
- Good manufacturing practice considerations for responding to COVID-19 infection in employees in drug and biological products manufacturing1
- Importation of certain FDA approved human prescription drugs, including biological products, and combination products under section 801(d)(1)(b) of the Federal Food, Drug, and Cosmetic Act1
- Mixing, diluting, or repackaging biological products outside the scope of an approved biologics license application1
- Osteoporosis: nonclinical evaluation of drugs intended for treatment1
- Pediatric information incorporated into human prescription drug and biological product labeling1
- Placebos and blinding in randomized controlled cancer clinical trials for drug and biological products1
- Regulatory considerations for human cells, tissues, and cellular and tissue-based products: minimal manipulation and homologous use : guidance for industry and Food and Drug Administration staff1
- Resuming normal drug and biologics manufacturing operations during the COVID-19 public health emergency1
- The "deemed to be a license" provision of the BPCI Act: questions and answers1