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Titles
- Pathological complete response in neoadjuvant treatment of high-risk early-stage breast cancer: use as an endpoint to support accelerated approval1
- Patient-focused drug development: collecting comprehensive and representative input : guidance for industry, Food and Drug Administration staff, and other stakeholders1
- 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
- Pediatric study plans: content of and process for submitting initial pediatric study plans and amended initial pediatric study plans1
- Peripheral vascular atherectomy devices: premarket notification [510(k)] submissions : guidance for industry and Food and Drug Administration staff1
- 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
- Policy for certain REMS requirements during the COVID-19 public health emergency: guidance for industry and health care professionals1
- Policy for coronavirus disease-2019 tests during the public health emergency (revised): immediately in effect guidance for clinical laboratories, commercial manufacturers, and Food and Drug Administration staff1
- Policy for temporary compounding of certain alcohol-based hand sanitizer products during the public health emergency: immediately in effect guidance for industry2
- Policy for the temporary use of portable cryogenic containers not in compliance with 21 CFR 211.94(e)(1) for oxygen and nitrogen during the COVID-19 public health emergency1
- Postmarketing adverse event reporting for medical products and dietary supplements during a pandemic1
- 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