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1542. 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.

1543. 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.

1544. 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.

1545. 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.

1546. 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.

1549. Association of patient out-of-pocket costs with prescription abandonment and delay in fills of novel oral anticancer agents

Author(s):
Doshi, Jalpa A., author
Li, Pengxiang, author
Huo, Hairong, author
Pettit, Amy R., author
Armstrong, Katrina A., author
Publication:
Philadelphia, PA : Leonard Davis Institute of Health Economics, 2018
Subject(s):
Antineoplastic Agents -- economics
Antineoplastic Agents -- therapeutic use
Drug Costs
Financing, Personal -- statistics & numerical data
Medication Adherence -- statistics & numerical data
Administration, Oral
Antineoplastic Agents -- administration & dosage
Health Services Accessibility
Prescription Drugs -- economics
Socioeconomic Factors
Time Factors
Humans
United States

1550. Show me the money: economic evaluations of opioid use disorder interventions

Author(s):
Murphy, Sean M., author
Polsky, Daniel, author
Meisel, Zachary, author
Mitchell, Julia, author
Publication:
Philadelphia, PA : Leonard Davis Institute of Health Economics, May 2016
Subject(s):
Opioid-Related Disorders -- drug therapy
Opioid-Related Disorders -- economics
Buprenorphine -- therapeutic use
Cost-Benefit Analysis
Methadone -- therapeutic use
Naltrexone -- therapeutic use
Reward
Humans
United States