Collections: Health Policy and Services Research / Subjects: United States. Food and Drug Administration. - Digital Collections - National Library of Medicine Search Results

Start Over Collections Health Policy and Services Research ✖ Subjects United States. Food and Drug Administration. ✖ Publication Year 2018 ✖

51. Unique device identification: policy regarding compliance dates for class I and unclassified devices : immediately in effect guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, January 16, 2018
Subject(s):: Equipment and Supplies -- classification
Product Labeling -- standards
Product Packaging -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

52. Compounded drug products that are essentially copies of a commercially available drug product under Section 503A of the Federal Food, Drug, and Cosmetic Act

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, January 2018
Subject(s):: Drug Compounding -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

53. Compounded drug products that are essentially copies of approved drug products under Section 503B of the Federal Food, Drug, and Cosmetic Act

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, January 2018
Subject(s):: Drug Compounding -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

54. Mixing, diluting, or repackaging biological products outside the scope of an approved biologics license application

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, January 2018
Subject(s):: Biological Products
Drug Approval
Drug Packaging
Prescription Drugs
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

55. Food safety: federal efforts to manage the risk of arsenic in rice : report to the Ranking Member, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies, Committee on Appropriations, House of Representatives

Publication:: Washington, DC : United States Government Accountability Office, March 2018
Subject(s):: Arsenic
Food Contamination -- prevention & control
Food Safety
Oryza
United States
United States. Department of Agriculture.
United States. Food and Drug Administration.

56. Orphan drugs: FDA could improve designation review consistency; rare disease drug development challenges continue : report to Congressional requesters

Publication:: Washington, DC : United States Government Accountability Office, November 2018
Subject(s):: Drug Approval
Orphan Drug Production
United States
United States. Food and Drug Administration.