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Titles
- FDA categorization of investigational device exemption (IDE) devices to assist the Centers for Medicare and Medicaid Services (CMS) with coverage decisions: guidance for sponsors, clinical investigators, industry, institutional review boards, and Food and Drug Administration staff1
- FY 2018 medical device user fee small business qualification and certification: guidance for industry, Food and Drug Administration staff and foreign governments1
- Facility definition under Section 503B of the Federal Food, Drug, and Cosmetic Act1
- Failure to respond to an ANDA complete response letter within the regulatory timeframe: guidance for industry1
- Foreign supplier verification programs for importers of food for humans and animals: guidance for industry1
- Form FDA 3674--certifications to accompany drug, biological product, and device applications/submissions: guidance for sponsors, industry, researchers, investigators, and food and drug administration staff1
- Formal dispute resolution: sponsor appeals above the division level : guidance for industry and review staff : good review practice1
- Formal meetings between FDA and ANDA applicants of complex products under GDUFA: guidance for industry1
- Format and content of a REMS document: guidance for industry1
- Fostering medical device improvement: FDA activities and engagement with the voluntary improvement program : guidance for industry and Food and Drug Administration staff1