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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 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
- 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
- Providing regulatory submissions for medical devices in electronic format: submissions under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act : guidance for industry and Food and Drug Administration staff1
- Providing regulatory submissions in electronic format: certain human pharmaceutical product applications and related submissions using the eCTD specifications1