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Start Over Subjects United States. Food and Drug Administration. ✖Remove constraint Subjects: United States. Food and Drug Administration. Genre Guideline ✖Remove constraint Genre: Guideline

111. 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.

114. Requirements for transactions with first responders under section 582 of the Federal Food, Drug, and Cosmetic Act--compliance policy

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, February 2017
Subject(s):
Emergency Medical Services -- legislation & jurisprudence
Emergency Responders -- legislation & jurisprudence
Pharmaceutical Preparations -- supply & distribution
Drug Therapy
Legislation, Drug
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

115. Providing regulatory submissions in electronic format--certain human pharmaceutical product applications and related submissions using the eCTD specifications

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, April 2017
Subject(s):
Automatic Data Processing -- standards
Investigational New Drug Application
Drug Approval -- legislation & jurisprudence
Drug Approval -- organization & administration
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.