Subjects: Drug Labeling and Humans / Copyright: Public domain - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Drug Labeling ✖ Subjects Humans ✖ Copyright Public domain ✖

1. Quality attribute considerations for chewable tablets

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2018
Subject(s):: Chemistry, Pharmaceutical
Drug Liberation
Mastication
Quality Control
Solubility
Tablets -- pharmacokinetics
Drug Approval
Drug Labeling
Hardness
Therapeutic Equivalency
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2. Recommended statement for over-the-counter aspirin-containing drug products labeled with cardiovascular related imagery

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, November 2017
Subject(s):: Aspirin
Drug Labeling
Drug Packaging
Nonprescription Drugs
Cardiovascular System
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3. Determining whether to submit an ANDA or a 505(b)(2) application

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2019
Subject(s):: Drug Approval
Drugs, Investigational
Investigational New Drug Application
Drug Labeling
Therapeutic Equivalency
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

4. Risk evaluation and mitigation strategies: modifications and revisions

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2019
Subject(s):: Risk Evaluation and Mitigation -- standards
Drug Approval
Drug Labeling
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

5. Oncology therapeutic radiopharmaceuticals: nonclinical studies and labeling recommendations

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2019
Subject(s):: Drug Evaluation, Preclinical -- standards
Neoplasms -- drug therapy
Radiopharmaceuticals -- pharmacology
Toxicity Tests
Carcinogenicity Tests
Drug Labeling
Lactation -- drug effects
Pharmacokinetics
Radiation Dosage
Animals
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6. Wholesale distributor verification requirement for saleable returned drug product: compliance policy

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2019
Subject(s):: Commerce -- legislation & jurisprudence
Legislation, Drug
Pharmaceutical Preparations -- standards
Drug Labeling
Drug Packaging
Guideline Adherence
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.