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Titles
- Pediatric information for x-ray imaging device premarket notifications: guidance for industry and Food and Drug Administration staff1
- Peripheral percutaneous transluminal angioplasty (PTA) and specialty catheters: premarket notification (510(k)) submissions : guidance for industry and Food and Drug Administration staff1
- Pharmacokinetic-based criteria for supporting alternative dosing regimens of programmed cell death receptor-1 (PD-1) or programmed cell death-ligand 1 (PD-L1) blocking antibodies for treatment of patients with cancer: guidance for industry1
- Physiologically based pharmacokinetic analyses--format and content1
- Policy for testing of alcohol (ethanol) and isopropyl alcohol for methanol: guidance for industry1
- Policy regarding N-acetyl-L-cysteine: guidance for industry1
- Postmarket surveillance under section 522 of the Federal Food, Drug, and Cosmetic Act: guidance for industry and Food and Drug Administration staff1
- Presenting quantitative efficacy and risk information in direct-to-consumer (DTC) promotional labeling and advertisements: guidance for industry1
- Procedures for handling post-approval studies imposed by premarket approval application order: guidance for industry and Food and Drug Administration staff1
- Procedures for meetings of the Medical Devices Advisory Committee: 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