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Titles
- Pediatric HIV infection: drug product development for treatment1
- Pediatric information for x-ray imaging device premarket notifications: guidance for industry and Food and Drug Administration staff1
- Pediatric information incorporated into human prescription drug and biological product labeling1
- Physiologically based pharmacokinetic analyses--format and content1
- Placebos and blinding in randomized controlled cancer clinical trials for drug and biological products1
- Policy clarification for certain fluoroscopic equipment requirements: guidance for industry and Food and Drug Administration staff1
- Premarket tobacco product applications for electronic nicotine delivery systems1
- Preparation of food contact notifications for food contact substances in contact with infant formula and/or human milk1
- Prescription Drug User Fee Act waivers, reductions, and refunds for drug and biological products1
- Procedures for meetings of the Medical Devices Advisory Committee: guidance for industry and Food and Drug Administration staff1
- Process to request a review of FDA's decision not to issue certain export certificates for devices: guidance for industry and Food and Drug Administration staff1
- Product labeling for certain ultrasonic surgical aspirator devices: guidance for Industry and Food and Drug Administration staff1
- Product name placement, size, and prominence in promotional labeling and advertisements1
- Providing regulatory submissions in electronic format--certain human pharmaceutical product applications and related submissions using the eCTD specifications1