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Start Over Subjects Drug Industry ✖Remove constraint Subjects: Drug Industry Genre Technical Report ✖Remove constraint Genre: Technical Report

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. Pharmacogenomics: a primer for policymakers

Publication:
Washington, D.C. : George Washington University, [2008]
Subject(s):
Genetic Testing
Insurance Coverage
Pharmacogenetics -- economics
Pharmacogenetics -- trends
Information Management
Cost-Benefit Analysis
Drug Industry
Health Policy
Health Services Accessibility
Health Services Research
Insurance, Pharmaceutical Services
Pharmaceutical Preparations
Pharmacogenetics -- ethics
Safety
Humans
United States

3. 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.

4. Antibiotics: FDA has encouraged development, but needs to clarify the role of draft guidance and develop qualified infectious disease product guidance : report to Congressional requesters

Publication:
Washington, D.C. : U.S. Government Accountability Office, January 2017
Subject(s):
Anti-Bacterial Agents -- therapeutic use
Drug Approval
Drug Industry
Drugs, Investigational
Investigational New Drug Application
Drug Resistance, Bacterial
Guidelines as Topic
Humans
United States
United States. Food and Drug Administration.

5. The prescription drug safety net: access to pharmaceuticals for the uninsured

Publication:
Washington, D.C. : George Washington University, [2007]
Subject(s):
Health Services Accessibility
Medical Assistance
Pharmaceutical Services
Uncompensated Care
Adult
Charities
Drug Industry
Drug Prescriptions -- economics
Economics, Pharmaceutical
Government Programs
HIV Infections -- drug therapy
Insurance, Pharmaceutical Services -- statistics & numerical data
Medically Uninsured
Middle Aged
Physician's Role
Practice Patterns, Physicians'
Humans
United States
United States. Health Resources and Services Administration.

6. 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.

11. 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.

14. 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.

15. 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.

18. Review timelines for applicant responses to complete response letters when a facility assessment is needed during the COVID-19 public health emergency

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, December 2020
Subject(s):
Correspondence as Topic
Drug Approval
Drug Industry
Facility Regulation and Control
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration