Collections: Health Policy and Services Research / Subjects: Drug Labeling and United States. Food and Drug Administration. - Digital Collections - National Library of Medicine Search Results

Start Over Collections Health Policy and Services Research ✖ Subjects Drug Labeling ✖ Subjects United States. Food and Drug Administration. ✖

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. Temporary policy on repackaging or combining propofol drug products during the COVID-19 public health emergency

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, Office of Pharmaceutical Quality and Office of Compliance, April 2020
Subject(s):: Drug Packaging -- methods
Propofol -- supply & distribution
COVID-19
Drug Labeling
Pharmacies
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4. Risk evaluation and mitigation strategies: modifications and revisions

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2020
Subject(s):: Drug Approval
Drug Industry
Drug Labeling
Risk Evaluation and Mitigation
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

5. Importation of certain FDA approved human prescription drugs, including biological products, and combination products under section 801(d)(1)(b) of the Federal Food, Drug, and Cosmetic Act

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2020
Subject(s):: Biological Products
Drug Labeling
Prescription Drugs
Counterfeit Drugs
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6. 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.

7. 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.

8. 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.

9. 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.