- 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 ...
- 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 ...
- ... 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 - 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 ...
- ... fields of science and have ready applicability to biomedical research. Such approaches include the rational designation and testing of hypotheses that are at least ...
- ... 4 for Pneumocystis Carinii Pneumonia have received "orphan" designation. Four grants for research on orphan drugs to treat AIDS have also been made. Vaccines | On August 18, FDA granted permission for the first clinical study in humans of an experimental AIDS vaccine. That ...
- NLM Digital Collections - Presidential Commission on the HIV Epidemic, hearing on Research, part 3, transcriptPublication: Produced: 20 February 1988... 4 for Pneumocystis Carinii Pneumonia have received "orphan" designation. Four grants for research on orphan drugs to treat AIDS have also been made. Vaccines | On August 18, FDA granted permission for the first clinical study in humans of an experimental AIDS vaccine. That ...
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