Titles
- Coordinated development of antimicrobial drugs and antimicrobial susceptibility test devices: guidance for industry and Food and Drug Administration staff1
- Delayed graft function in kidney transplantation: developing drugs for prevention1
- Determining whether to submit an ANDA or a 505(b)(2) application1
- Drugs for treatment of partial onset seizures: full extrapolation of efficacy from adults to pediatric patients 2 years of age and older1
- Electronic capabilities for patient engagement among U.S. non-federal acute care hospitals: 2013-20171
- Electronic prescribing of controlled substances among Medicare Part D prescribers: 2015-20161
- Electronic prescribing of controlled substances among office-based physicians: 20171
- Enrichment strategies for clinical trials to support determination of effectiveness of human drugs and biological products1
- Epidermolysis bullosa: developing drugs for treatment of cutaneous manifestations1
- Evaluation of devices used with regenerative medicine advanced therapies1
- Evaluation of internal standard responses during chromatographic bioanalysis: questions and answers1
- Extending expiration dates of doxycycline tablets and capsules in strategic stockpiles: guidance for government public health and emergency response stakeholders1
- Extension of certain tobacco product compliance deadlines related to the final deeming rule: (revised)1
- FDA deems certain tobacco products subject to FDA authority, sales and distribution restrictions, and health warning requirements for packages and advertisements: (revised)1
- 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
- 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
- Further testing of donations that are reactive on a licensed donor screening test for antibodies to hepatitis C virus1
- Hospitals' use of electronic health records data: 2015-20171
- Human immunodeficiency virus-1 infection: developing systemic drug products for pre-exposure prophylaxis1