1. Foster care: HHS has taken steps to support states' oversight of psychotropic medications, but additional assistance could further collaboration : report to Congressional requesters
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2. 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 Representatives
3. Drug-free community support program: agencies have strengthened collaboration but could enhance grantee compliance and performance monitoring : report to Congressional committees
4. Requirements for transactions with first responders under section 582 of the Federal Food, Drug, and Cosmetic Act--compliance policy
5. Providing regulatory submissions in electronic format--certain human pharmaceutical product applications and related submissions using the eCTD specifications
6. Emergency use authorization of medical products and related authorities: guidance for industry and other stakeholders
7. Form FDA 3674--certifications to accompany drug, biological product, and device applications/submissions: guidance for sponsors, industry, researchers, investigators, and food and drug administration staff
8. E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs--questions and answers (R3)
9. Q3C--tables and list
10. 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 boards
11. M4E(R2): the CTD--efficacy
12. Consumer antiseptic wash final rule: questions and answers : (Small Entity Compliance Guide)
13. Generic Drug User Fee Amendments of 2012: questions and answers related to self-identification of facilities, review of generic drug submissions, and inspections and compliance
14. Antibacterial therapies for patients with an unmet medical need for the treatment of serious bacterial diseases
15. FY 2018 medical device user fee small business qualification and certification: guidance for industry, Food and Drug Administration staff and foreign governments
16. Use of real-world evidence to support regulatory decision-making for medical devices: guidance for industry and Food and Drug Administration staff
17. Procedures for meetings of the Medical Devices Advisory Committee: guidance for industry and Food and Drug Administration staff
18. Design considerations and pre-market submission recommendations for interoperable medical devices: guidance for industry and Food and Drug Administration staff
19. Evaluation and reporting of age-, race-, and ethnicity-specific data in medical device clinical studies: guidance for Industry and Food and Drug Administration staff
20. 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 staff
