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Start Over Collections Health Policy and Services Research ✖Remove constraint Collections: Health Policy and Services Research Subjects Drug Industry ✖Remove constraint Subjects: Drug Industry Subjects United States. Department of Health and Human Services. ✖Remove constraint Subjects: United States. Department of Health and Human Services.

1. Drug supply chain security: dispensers received most tracing information

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, March 2018
Subject(s):
Pharmaceutical Preparations -- supply & distribution
Prescription Drug Diversion
Drug Industry
Information Dissemination
Pharmacies
Security Measures
Humans
United States
United States. Department of Health and Human Services.

2. Drug and device manufacturer communications with payors, formulary committees, and similar entities: questions and answers : guidance for industry and review staff

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, June 2018
Subject(s):
Communication
Equipment and Supplies -- economics
Insurance, Health, Reimbursement -- economics
Pharmaceutical Preparations -- economics
Truth Disclosure
Costs and Cost Analysis
Device Approval
Drug Approval
Drug Industry
Information Dissemination
Outcome Assessment (Health Care) -- economics
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3. 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.

4. Good manufacturing practice considerations for responding to COVID-19 infection in employees in drug and biological products manufacturing

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, June 2020
Subject(s):
Biological Products
COVID-19 -- prevention & control
Drug Industry
Manufacturing and Industrial Facilities
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

7. COVID-19 public health emergency: general considerations for pre-IND meeting requests for COVID-19 related drugs and biological products : guidance for industry and investigators

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, May 2020
Subject(s):
Biological Products
COVID-19 -- drug therapy
Drug Approval
Drug Industry
Drugs, Investigational
Drug Evaluation, Preclinical
Investigational New Drug Application
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

8. Wholesale distributor verification requirement for saleable returned drug product and dispenser verification requirements when investigating a suspect or illegitimate product: compliance policies

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, October 2020
Subject(s):
Drug Industry
Drug and Narcotic Control
Pharmaceutical Preparations
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.