Subjects: Guideline Adherence / Copyright: Public domain - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Guideline Adherence ✖ Copyright Public domain ✖

11. Compliance policy for certain compounding of oral oxitriptan (5-HTP) drug products for patients with tetrahydrobiopterin (BH4) deficiency: immediately in effect guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2019
Subject(s):: Drug Compounding -- standards
5-Hydroxytryptophan -- therapeutic use
Phenylketonurias -- drug therapy
Guideline Adherence
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

12. Wholesale distributor verification requirement for saleable returned drug product: compliance policy

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2019
Subject(s):: Commerce -- legislation & jurisprudence
Legislation, Drug
Pharmaceutical Preparations -- standards
Drug Labeling
Drug Packaging
Guideline Adherence
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

13. Enforcement policy for non-invasive remote monitoring devices used to support patient monitoring: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, October 19, 2023
Subject(s):: Equipment Safety
Government Regulation
Guideline Adherence
Monitoring, Physiologic
Remote Sensing Technology
United States

14. Compliance policy regarding blood and blood component donation suitability, donor eligibility and source plasma quarantine hold requirements: guidance for industry

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, October 2023
Subject(s):: Blood Banking -- standards
Blood Donation -- standards
Blood Donors
Donor Selection -- standards
Government Regulation
Guideline Adherence
Plasma
United States

15. Enforcement policy for clinical electronic thermometers: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, November 3, 2023
Subject(s):: Device Approval
Government Regulation
Guideline Adherence
Thermometers -- standards
United States

16. Enforcement policy for certain supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) submissions: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, November 2, 2023
Subject(s):: Compassionate Use Trials
Device Approval
Government Regulation
Guideline Adherence
United States

17. New Jersey could better ensure that nursing homes comply with federal requirements for life safety, emergency preparedness, and infection control

Publication:: [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2023
Subject(s):: Disaster Planning -- standards
Government Regulation
Guideline Adherence
Infection Control -- standards
Nursing Homes -- legislation & jurisprudence
Nursing Homes -- standards
Safety Management -- standards
New Jersey