- NLM Digital Collections - Report of the Surgeon General's Workshop on Children with HIV Infection and Their FamiliesPublication: United States Public Health Service, [1987]... units as a foundation and incorporating the pending clinical studies groups. Our group recommends the designation of an executive director to assure efficient and ...
- NLM Digital Collections - Report of the Surgeon General's Workshop on Children with HIV Infection and Their Families ...Publication: United States Public Health Service, [1987]... units as a foundation and incorporating the pending clinical studies groups. Our group recommends the designation of an executive director to assure efficient and ...
- NLM Digital Collections - Requesting FDA feedback on combination products : guidance for industry and FDA staffPublication: Silver Spring, MD : Center for Biologics Evaluation and Research, December 2020... or where there are questions related to a clinical Humanitarian study design Device Exemption Requests for designation of device-led Designation Request (HDE) combination products ...
- NLM Digital Collections - A review of the United States role in international biomedical research and communications : ....Publication: Bethesda, Md. : U. S. Dept. of Health and Human Services, Public Health Service, National Institutes of Health, National Library of Medicine ; [Washington, D.C. : For sale by the Supt. of Docs., U.S. G.P.O.], 1980... State Fact Sheet on Bilaterals (1977). 266 / International Biomedical Research and Communications role by State, oftentimes the designation of the National Science Foundation (NSF) as the " ...
- ... charts should be made accurate, though perhaps the clinical designation need not be precise. (5) A careful study shows that it is impossible to work out ...
- ... fields of science and have ready applicability to biomedical research. Such approaches include the rational designation and testing of hypotheses, at least loosely driven ...
- NLM Digital Collections - Breakthrough Devices Program : guidance for industry and Food and Drug Administration staffPublication: Silver Spring, MD : Center for Devices and Radiological Health, September 15, 2023... granted (see Appendix 1: Illustrative Example: Breakthrough Device Designation Request). Data ... Method, Non-clinical Test Acceptance Criteria, ...
- NLM Digital Collections - Orphan drugs : FDA could improve designation review consistency; rare disease drug ...Publication: Washington, DC : United States Government Accountability Office, November 2018... than one area of concern with the manufacturer’s designation application. 24 According to OOPD policy, the scientific rationale is best supported by clinical data from human studies; however, in the absence of this data, manufacturers ...
- NLM Digital Collections - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1:...Publication: Silver Spring, MD : Center for Devices and Radiological Health, September 8, 2023... and through the review of devices granted Breakthrough designation and determines, through our benefit-risk analysis, what biocompatibility endpoints should be evaluated prior to initiation of clinical studies as well as what evaluations may be appropriately ...
- NLM Digital Collections - Use of International Standard ISO 10993-1 : "Biological evaluation of medical devices - part ....Publication: Silver Spring, MD : Center for Devices and Radiological Health, September 4, 2020... and through the review of devices granted Breakthrough designation and determines, through our benefit-risk analysis, what biocompatibility endpoints are necessary for evaluation prior to initiation of clinical studies as well as what evaluations may be appropriately ...
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