Subjects: United States and United States. Department of Health and Human Services - Digital Collections - National Library of Medicine Search Results

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31. Requesting FDA feedback on combination products: guidance for industry and FDA staff

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, December 2020
Subject(s):: Biological Products
Formative Feedback
Legislation, Drug
Medical Device Legislation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

32. Drug misuse: agencies have not fully identified how grants that can support drug prevention education programs contribute to national goals : report to Congress

Publication:: Washington, DC : United States Government Accountability Office, November 2020
Subject(s):: Health Education
Program Evaluation
School Health Services
Substance-Related Disorders -- prevention & control
Federal Government
United States
United States. Department of Health and Human Services

33. Rural hospital closures: affected residents had reduced access to health care services : report to the ranking member, Committee on Homeland Security and Governmental Affairs, United States Senate

Publication:: Washington, DC : United States Government Accountability Office, December 2020
Subject(s):: Health Facility Closure
Health Services Accessibility
Hospitals, Rural -- suply & distribution
Rural Health Services -- supply & distribution
United States
United States. Department of Health and Human Services

34. Policy for testing of alcohol (ethanol) and isopropyl alcohol for methanol, including during the public health emergency (COVID-19)

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, January 2021
Subject(s):: 2-Propanol
Drug Compounding
Ethanol
Methanol
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

35. Protecting participants in bioequivalence studies for abbreviated new drug applications during the COVID-19 public health emergency

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, January 2021
Subject(s):: Drug Approval
Patient Safety
Therapeutic Equivalency
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

36. COVID-19: potency assay considerations for monoclonal antibodies and other therapeutic proteins targeting SARS-CoV-2 infectivity

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, January 2021
Subject(s):: Antibodies, Monoclonal
COVID-19 -- drug therapy
Enzyme-Linked Immunosorbent Assay
SARS-CoV-2
Viral Plaque Assay
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

37. Requests for feedback and meetings for medical device submissions: the Q-Submission Program : guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, January 6, 2021
Subject(s):: Device Approval
Formative Feedback
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

38. Safer technologies program for medical devices: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, January 6, 2021
Subject(s):: Device Approval
Equipment Safety
Voluntary Programs
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

39. Mouse embryo assay for assisted reproduction technology devices: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, January 5, 2021
Subject(s):: Biological Assay
Device Approval
Embryo, Mammalian
Mice
Reproductive Techniques, Assisted
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

40. Consumer Antiseptic Rub Final Rule: questions and answers : small entity compliance guide

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2020
Subject(s):: Hand Sanitizers -- chemistry
Hand Sanitizers -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

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