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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 deems certain tobacco products subject to FDA authority, sales and distribution restrictions, and health warning requirements for packages and advertisements: (revised)1
- FDA oversight of tobacco manufacturing establishments1
- FDA should further integrate its review of cybersecurity into the premarket review process for medical devices1
- 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
- Factors to consider when making benefit-risk determinations in medical device premarket approval and de novo classifications: guidance for industry and Food and Drug Administration staff1
- Federal Medicaid policy1
- Followup review: CMS's management of the quality payment program1
- Food labeling: serving sizes of foods that can reasonably be consumed at one eating occasion, reference amounts customarily consumed, serving size-related issues, dual-column labeling, and miscellaneous topics1
- 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
- Foster care: HHS has taken steps to support states' oversight of psychotropic medications, but additional assistance could further collaboration : report to Congressional requesters1
- Further testing of donations that are reactive on a licensed donor screening test for antibodies to hepatitis C virus1