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Titles
- Data inadequacies undermine CMS's oversight of the inconsistency resolution process for the federal marketplace1
- De novo classification process (evaluation of automatic class III designation): guidance for industry and Food and Drug Administration staff1
- Deciding when to submit a 510(k) for a change to an existing device: guidance for Industry and Food and Drug Administration staff1
- Deciding when to submit a 510(k) for a software change to an existing device: guidance for industry and Food and Drug Administration staff1
- Defense civil support: DOD, HHS, and DHS should use existing coordination mechanisms to improve their pandemic preparedness : report to the Committee on Armed Services, House of Representatives1
- Delayed graft function in kidney transplantation: developing drugs for prevention1
- Delivery reform1
- Design considerations and pre-market submission recommendations for interoperable medical devices: guidance for industry and Food and Drug Administration staff1
- Determining whether to submit an ANDA or a 505(b)(2) application1
- Developing and responding to deficiencies in accordance with the least burdensome provisions: guidance for industry and Food and Drug Administration staff1
- Disparities in health and health care: five key questions and answers1
- Display devices for diagnostic radiology: guidance for industry and Food and Drug Administration staff1
- Dissolution testing and acceptance criteria for immediate-release solid oral dosage form drug products containing high solubility drug substances1
- Drug and device manufacturer communications with payors, formulary committees, and similar entities: questions and answers : guidance for industry and review staff1
- Drug supply chain security: dispensers received most tracing information1
- Drug supply chain security: wholesalers exchange most tracing information1
- Drug-free community support program: agencies have strengthened collaboration but could enhance grantee compliance and performance monitoring : report to Congressional committees1
- Drugs for treatment of partial onset seizures: full extrapolation of efficacy from adults to pediatric patients 2 years of age and older1
- Duchenne muscular dystrophy and related dystrophinopathies: developing drugs for treatment1