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Start Over Subjects United States. Department of Health and Human Services. ✖Remove constraint Subjects: United States. Department of Health and Human Services. Subjects United States. Food and Drug Administration. ✖Remove constraint Subjects: United States. Food and Drug Administration. Copyright Public domain ✖Remove constraint Copyright: Public domain

111. 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.

112. 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.

113. 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.

114. 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.

115. 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.

118. 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.

119. 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.

120. Pathological complete response in neoadjuvant treatment of high-risk early-stage breast cancer: use as an endpoint to support accelerated approval

Publication:
[Silver Spring, MD] : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
Subject(s):
Breast Neoplasms
Clinical Trials as Topic
Neoadjuvant Therapy
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.