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6311. Nonclinical testing of orally inhaled nicotine-containing drug products

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2020
Subject(s):: Administration, Inhalation
Tobacco Use Cessation Devices
Toxicity Tests
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

6312. Referencing approved drug products in ANDA submissions

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2020
Subject(s):: Drug Approval
Drugs, Generic
Reference Books, Medical
Therapeutic Equivalency
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

6313. Indian Health Service: actions needed to improve oversight of federal facilities' decision-making about the use of funds : report to Congressional addressees

Publication:: Washington, DC : United States Government Accountability Office, November 2020
Subject(s):: Alaskan Natives
American Natives
Government Regulation
Health Facility Administration
United States
United States. Indian Health Service

6314. Medicaid eligibility: accurate beneficiary enrollment requires improvements in oversight, data, and collaboration : testimony before the Subcommittee on Health Care, Committee on Finance, U.S. Senate

Publication:: Washington, DC : United States Government Accountability Office, October 30, 2019
Subject(s):: Eligibility Determination
Government Regulation
Medicaid -- economics
United States
United States.
Centers for Medicare & Medicaid Services (U.S.)

6315. Conduct of clinical trials of medical products during the COVID-19 public health emergency: guidance for industry, investigators, and institutional review boards

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, August 30, 2021
Subject(s):: Clinical Trial Protocols as Topic
Clinical Trials as Topic -- methods
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

6316. Financial analysis 2019: an annual report on the financial health of Pennsylvania hospitals. Volume one, General acute care hospitals

Publication:: Harrisburg, PA : Pennsylvania Health Care Cost Containment Council, April 2020
Subject(s):: Economics, Hospital -- statistics & numerical data
Hospitals, General -- economics
Hospitals, General -- statistics & numerical data
Pennsylvania
United States

6317. Notifying CDRH of a permanent discontinuance or interruption in manufacturing of a device under Section 506J of the FD&C Act during the COVID-19 public health emergency (revised): guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, November 2020
Subject(s):: Equipment and Supplies
Manufacturing Industry
Medical Device Legislation
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

6318. VA acquisition management: actions needed to improve management of medical-surgical prime vendor program and inform future decisions : report to Congressional requesters

Publication:: Washington, DC : United States Government Accountability Office, September 2020
Subject(s):: Equipment and Supplies -- economics
Government Regulation
Veterans
United States
United States. Department of Veterans Affairs

6319. Qualification process for drug development tools: guidance for industry and FDA staff

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, November 2020
Subject(s):: Drug Approval
Drug Development -- methods
Drug Development -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

6320. Formal meetings between FDA and ANDA applicants of complex products under GDUFA

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

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