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Start Over Subjects Investigational New Drug Application ✖Remove constraint Subjects: Investigational New Drug Application Genre Guideline ✖Remove constraint Genre: Guideline

12. General principles for evaluating the abuse deterrence of generic solid oral opioid drug products

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, November 2017
Subject(s):
Abuse-Deterrent Formulations -- standards
Analgesics, Opioid -- administration & dosage
Drugs, Generic
Investigational New Drug Application
Administration, Oral
Administration, Inhalation
Clinical Trials as Topic
Drug Evaluation, Preclinical
Injections
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

13. 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.

14. 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.

15. 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.

16. 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.