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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
- FDA medical device reviews: evaluation is needed to assure requests for additional information follow a least burdensome approach : report to Congressional requestors1
- FDA oversight of tobacco manufacturing establishments1
- FY 2018 medical device user fee small business qualification and certification: guidance for industry, Food and Drug Administration staff and foreign governments1
- Food Safety: a national strategy is needed to address fragmentation in federal oversight : report to Congressional requesters1
- Food safety: FDA continues to evaluate and respond to business concerns about the produce rule : report to Congressional committees1
- 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