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

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41. 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

42. Effects of the COVID-19 public health emergency on formal meetings and user fee applications for medical devices: questions and answers (revised) : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, June 2020
Subject(s):: Device Approval
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

43. Enforcement policy for the Quality Standards of the Mammography Quality Standards Act during the COVID-19 public health emergency: guidance for mammography facilities, state MQSA contract partners, FDA approved MQSA accreditation bodies, and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, December 2020
Subject(s):: Facility Regulation and Control
Mammography -- standards
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

44. Product labeling for laparoscopic power morcellators: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, December 30, 2020
Subject(s):: Laparoscopy
Morcellation
Product Labeling
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

45. Providing regulatory submissions in electronic format: content of the risk evaluation and mitigation strategies document using structured product labeling

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2020
Subject(s):: Drug Approval
Risk Evaluation and Mitigation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

46. Review timelines for applicant responses to complete response letters when a facility assessment is needed during the COVID-19 public health emergency

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, December 2020
Subject(s):: Correspondence as Topic
Drug Approval
Drug Industry
Facility Regulation and Control
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

47. COVID-19: federal efforts accelerate vaccine and therapeutic development, but more transparency needed on emergency use authorizations : report to Congressional addressees

Publication:: Washington, DC : United States Government Accountability Office, November 2020
Subject(s):: COVID-19 Vaccines
Drug Approval
Drug Development
Disclosure
United States
United States. Department of Defense
United States. Department of Health and Human Services

48. Geographic disparities affect access to buprenorphine services for opioid use disorder

Publication:: [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, January 2020
Subject(s):: Buprenorphine -- supply & distribution
Health Services Accessibility
Medically Underserved Area
Opiate Substitution Treatment
Opioid-Related Disorders -- drug therapy
United States
United States. Department of Health and Human Services
United States. Substance Abuse and Mental Health Services Administration

49. Indian Health Service has strengthened patient protection policies but must fully integrate them into practice and organizational culture

Publication:: [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, December 2019
Subject(s):: American Natives
Alaskan Natives
Child Abuse, Sexual -- prevention & control
Patients
Sex Offenses -- prevention & control
United States
United States. Department of Health and Human Services
United States. Indian Health Service

50. Billions in estimated Medicare Advantage payments from chart reviews raise concerns

Publication:: [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, December 2019
Subject(s):: Insurance, Health, Reimbursement
Medical Records -- economics
Medicare Part C -- economics
Quality of Health Care
Risk Adjustment
United States
United States. Department of Health and Human Services
Centers for Medicare & Medicaid Services (U.S.)

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