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1. Duchenne muscular dystrophy and related dystrophinopathies: developing drugs for treatment

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, February 2018

Subject(s):

Clinical Trials as Topic -- standards
Drug Evaluation -- standards
Muscular Dystrophies -- drug therapy
Muscular Dystrophy, Duchenne -- drug therapy
Drug Labeling -- standards
Drugs, Investigational
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2. Q7 good manufacturing practice guidance for active pharmaceutical ingredients: questions and answers

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, April 2018

Subject(s):

Chemistry, Pharmaceutical -- standards
Pharmaceutical Preparations -- standards
Quality Control
Drug Contamination
Drug Labeling -- standards
International Cooperation
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3. Complicated intra-abdominal infections: developing drugs for treatment

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, May 2018

Subject(s):

Anti-Bacterial Agents -- therapeutic use
Clinical Trials as Topic
Drug Evaluation -- standards
Drugs, Investigational -- pharmacokinetics
Intraabdominal Infections -- drug therapy
Microbiological Techniques -- standards
Drug Labeling -- standards
Endpoint Determination -- standards
Research Design -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4. Medical product communications that are consistent with the FDA-required labeling: questions and answers

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, June 2018

Subject(s):

Communication
Drug Labeling -- standards
Product Labeling -- standards
Equipment and Supplies -- standards
Pharmaceutical Preparations -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

5. Labeling for biosimilar products

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, July 2018

Subject(s):

Biosimilar Pharmaceuticals
Drug Labeling -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6. 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.

7. [Remedies for diabetes, gall stones, and heart conditions]

Publication:

1910

Subject(s):

Pharmaceutical Preparations -- standards
Drug Labeling -- standards

8. Medication literacy series. Prescription drug container labels

Author(s):

McSpadden, James, author

Publication:

Washington, DC : AARP Public Policy Institute, November 2022

Subject(s):

Drug Labeling -- methods
Drug Labeling -- standards
Health Literacy
Prescription Drugs
Aged
Consumer Product Safety
Health Policy
United States

9. Expiration dating of unit-dose repackaged solid oral dosage form drug products

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, July 2020

Subject(s):

Administration, Oral
Drug Labeling -- standards
Drug Packaging -- standards
Time Factors
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

10. Providing regulatory submissions in electronic and non-electronic format: promotional labeling and advertising materials for human prescription drugs

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, April 2022

Subject(s):

Advertising -- legislation & jurisprudence
Advertising -- standards
Drug Approval
Drug Labeling -- legislation & jurisprudence
Drug Labeling -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration