- Elemental impurities in drug products1
- Emergency use authorization of medical products and related authorities: guidance for industry and other stakeholders1
- Enforcement policy--OTC sunscreen drug products marketed without an approved application1
- Establishing effectiveness for drugs intended to treat male hypogonadotropic hypogonadism attributed to nonstructural disorders1
- Establishing the performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of human papillomaviruses: guidance for Industry and Food and Drug Administration staff1
- Evaluating drug effects on the ability to operate a motor vehicle1
- Evaluation and reporting of age-, race-, and ethnicity-specific data in medical device clinical studies: guidance for Industry and Food and Drug Administration staff1
- Extension of certain tobacco product compliance deadlines related to the final deeming rule: (revised)1
- 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
- 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
- General principles for evaluating the abuse deterrence of generic solid oral opioid drug products1
- Generic Drug User Fee Amendments of 2012: questions and answers related to self-identification of facilities, review of generic drug submissions, and inspections and compliance1
- Health document submission requirements for tobacco products: (revised)1
- How to prepare a pre-request for designation (pre-RFD)1
- IRB waiver or alteration of informed consent for clinical investigations involving no more than minimal risk to human subjects: guidance for sponsors, investigators, and institutional review boards1
- Labeling for biosimilar products1
- Liposome drug products: chemistry, manufacturing, and controls : human pharmacokinetics and bioavailability : and labeling documentation1