Languages: English / Copyright: Public domain / Dates by Range: 2000 and later - Digital Collections - National Library of Medicine Search Results

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551. Product name placement, size, and prominence in promotional labeling and advertisements

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2017
Subject(s):: Advertising as Topic -- standards
Prescription Drugs -- standards
Product Labeling -- standards
Mass Media
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

552. Systemic antibacterial and antifungal drugs: susceptibility test interpretive criteria labeling for NDAs and ANDAs

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2017
Subject(s):: Antibacterial Agents
Antifungal Agents
Drug Labeling -- standards
Investigational New Drug Application
Microbial Sensitivity Tests
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

553. Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2017
Subject(s):: Biological Availability
Drugs, Investigational -- pharmacokinetics
Investigational New Drug Application
Therapeutic Equivalency
Administration, Oral
Biopharmaceutics -- classification
Drugs, Investigational -- administration & dosage
Excipients
Permeability
Prodrugs
Solubility
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

554. Best practices for communication between IND sponsors and FDA during drug development: guidance for industry and review staff : good review practice

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2017
Subject(s):: Communication
Drug Industry
Investigational New Drug Application
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

555. 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.

556. 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.

557. 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.

558. 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.

559. Demystifying medicine: a novel FAES graduate school course for PhD scientists and students, spring semester 2002

Publication:: [Bethesda, Md. : Medical Arts and Photography Branch, National Institutes of Health, 2002]
Subject(s):: Medicine
Science
Education, Graduate

560. The physician, the intern, and the patient: artifacts from the first documented description of sickle cell anemia, on view in the History of Medicine Division Reading Room

Publication:: [Bethesda, Md. : National Library of Medicine, 2010]
Subject(s):: Anemia, Sickle Cell
Herrick, James B. (James Bryan), 1861-1954.
Irons, Ernest E. (Ernest Edward), 1877-

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