- Evaluation of devices used with regenerative medicine advanced therapies1
- Evaluation of internal standard responses during chromatographic bioanalysis: questions and answers1
- Evaluation of the Medi-Cal Plan/Practice Improvement Project: executive summary1
- Exploring the role of cost-benefit analysis in government regulations1
- Extending expiration dates of doxycycline tablets and capsules in strategic stockpiles: guidance for government public health and emergency response stakeholders1
- 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 medical device reviews: evaluation is needed to assure requests for additional information follow a least burdensome approach : report to Congressional requestors1
- FDA oversight1
- 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
- Financing county Medi-Cal eligibility and enrollment in California1
- Food Safety: a national strategy is needed to address fragmentation in federal oversight : report to Congressional requesters1
- 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
- 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