Subjects: 3 selected - Digital Collections - National Library of Medicine Search Results

Start Over Subjects United States ✖ Subjects United States. ✖ Subjects United States. Department of Health and Human Services. ✖

31. Center for Devices and Radiological Health (CDRH) appeals processes: questions and answers about 517A : guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, March 27, 2020
Subject(s):: Device Approval
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

32. Summary of HHS's final rule on nondiscrimination in health programs and activities

Author(s):: Cornachione, Elizabeth, author
Musumeci, MaryBeth, author
Artiga, Samantha, author
Publication:: Menlo Park, CA : Henry J. Kaiser Family Foundation, July 2016
Subject(s):: Delivery of Health Care -- organization & administration
Health Services Accessibility
Prejudice -- prevention & control
Social Discrimination -- prevention & control
United States
United States. Department of Health and Human Services.
United States.

33. Administrative rulemaking

Author(s):: Berry, Melissa D., author
Publication:: [Toronto, Ontario] : Thomson Reuters, 23-December-2019
Subject(s):: Health Care Reform -- legislation & jurisprudence
Advertising -- legislation & jurisprudence
Conscientious Refusal to Treat -- legislation & jurisprudence
Contraception
Drug Costs
Emergency Medical Services -- legislation & jurisprudence
Emigrants and Immigrants -- legislation & jurisprudence
Hospital Costs
Insurance, Health, Reimbursement
Long-Term Care
Medicaid -- legislation & jurisprudence
Medicare -- legislation & jurisprudence
Politics
Taxes
Transportation of Patients -- legislation & jurisprudence
Humans
United States
United States. Department of Health and Human Services.
United States.
Centers for Medicare & Medicaid Services (U.S.)

34. Federal Medicaid policy

Author(s):: Raduege, Tammy J., author
Publication:: [Toronto, Ontario] : Thomson Reuters, 23-December-2019
Subject(s):: Medicaid -- organization & administration
Federal Government
Health Policy
Community Health Services -- legislation & jurisprudence
Eligibility Determination -- legislation & jurisprudence
Healthcare Disparities -- legislation & jurisprudence
Home Care Services -- legislation & jurisprudence
Managed Care Programs -- legislation & jurisprudence
Medicaid -- legislation & jurisprudence
Mental Health Services -- legislation & jurisprudence
Reproductive Health Services -- legislation & jurisprudence
Rural Health Services -- legislation & jurisprudence
Social Support
Humans
United States
United States. Department of Health and Human Services.
United States.
Centers for Medicare & Medicaid Services (U.S.)

35. Interpretation of and compliance policy for certain label requirement: applicability of certain Federal Food, Drug, and Cosmetic Act requirements to vape shops

Publication:: Silver Spring, MD : Food and Drug Administration, Center for Tobacco Products, March 2019
Subject(s):: Electronic Nicotine Delivery Systems -- standards
Product Labeling -- legislation & jurisprudence
Tobacco Products -- legislation & jurisprudence
Product Labeling -- standards
Vaping -- legislation & jurisprudence
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

36. REMS: FDA's application of statutory factors in determining when a REMS is necessary

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2019
Subject(s):: Drug Evaluation -- legislation & jurisprudence
Risk Evaluation and Mitigation -- legislation & jurisprudence
Cost of Illness
Drug-Related Side Effects and Adverse Reactions
Health Services Accessibility
Prescription Drugs -- adverse effects
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

37. Extending expiration dates of doxycycline tablets and capsules in strategic stockpiles: guidance for government public health and emergency response stakeholders

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2019
Subject(s):: Anthrax -- drug therapy
Civil Defense
Doxycycline -- supply & distribution
Doxycycline -- therapeutic use
Post-Exposure Prophylaxis
Strategic Stockpile
Biological Availability
Drug Stability
Drug Storage
Legislation, Drug
Biological Availability
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

38. 30-Day notices, 135-day premarket approval (PMA) supplements and 75-day humanitarian device exemption (HDE) supplements for manufacturing method or process changes: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, December 16, 2019
Subject(s):: Device Approval -- standards
Equipment and Supplies -- standards
Manufactured Materials -- standards
Device Approval -- legislation & jurisprudence
Time Factors
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

39. Determining whether to submit an ANDA or a 505(b)(2) application

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2019
Subject(s):: Drug Approval
Drugs, Investigational
Investigational New Drug Application
Drug Labeling
Therapeutic Equivalency
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

40. FDA deems certain tobacco products subject to FDA authority, sales and distribution restrictions, and health warning requirements for packages and advertisements: (revised)

Publication:: Silver Spring, MD : Food and Drug Administration, Center for Tobacco Products, March 2019
Subject(s):: Commerce -- legislation & jurisprudence
Product Labeling -- legislation & jurisprudence
Tobacco Products -- legislation & jurisprudence
Tobacco Products -- supply & distribution
Advertising -- legislation & jurisprudence
Tobacco Products -- adverse effects
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.