Formats: Text / Subjects: Humans and United States. Department of Health and Human Services. / Genre: Technical Report and Guideline / Dates by Range: 2000 and later - Digital Collections - National Library of Medicine Search Results

Start Over Formats Text ✖ Subjects Humans ✖ Subjects United States. Department of Health and Human Services. ✖ Genre Technical Report ✖ Genre Guideline ✖ Dates by Range 2000 and later ✖

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.

112. 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.

113. 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.

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.

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