Subjects: Drug Industry -- standards - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Drug Industry -- standards ✖

1. Facility definition under Section 503B of the Federal Food, Drug, and Cosmetic Act

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

2. Generic Drug User Fee Amendments of 2012: questions and answers related to self-identification of facilities, review of generic drug submissions, and inspections and compliance

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2017
Subject(s):: Drug Approval
Drug Industry -- standards
Drugs, Generic
Guideline Adherence
Investigational New Drug Application
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3. Advancement of emerging technology applications for pharmaceutical innovation and modernization

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2017
Subject(s):: Biomedical Technology -- standards
Drug Industry -- standards
Inventions
Quality Assurance, Health Care
Quality Improvement
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4. Insanitary conditions at compounding facilities

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, November 2020
Subject(s):: Drug Compounding
Drug Industry -- standards
Facility Regulation and Control
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration