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Start Over Subjects Drug Industry ✖Remove constraint Subjects: Drug Industry

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.

8. Drugs resources: manufacturers, importers, processors : biologicals, botanicals, containers, fish liver oils, narcotics, hormones and glandular substances, medicinal chemicals, surgical dressings

Author(s):
Morgan, Clifford V., author
Baumann, Chas. A., author
Publication:
Washington, D.C. : War Department, Office of the Under Secretary of War, October 1941
Subject(s):
Drug Industry
Pharmaceutical Preparations
Drug and Narcotic Control
United States

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 Antibiotics: FDA has encouraged development, but needs to clarify the role of draft guidance and develop qualified infectious disease product guidance : report to Congressional requesters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

13. Pharmaceuticals and insecticides at I.G. Farben plants Elberfeld and Leverkusen

Author(s):
Curtis, Francis J., author
Davis, Fenimore C., author
Smadel, Joseph E. (Joseph Edwin), 1907-1963, author
Southworth, Hamilton, 1907-1994, author
Volwiler, Ernest H., 1893-1992, author
Publication:
[London?] : Combined Intelligence Objectives Sub-Committee, [1945]
Subject(s):
Drug Industry
Technology, Pharmaceutical
Pharmaceutical Preparations
Insecticides
World War II
Germany
Interessengemeinschaft Farbenindustrie Aktiengesellschaft.

21. Pharmaceutical targets: Nordmark Werke - Utersen, Germany, I.G. Farben - Leverkusen, Germany, I.G. Farben - Hochst, Germany, Behringwerke - Marburg, Germany, E. Merck - Darmstadt, Germany

Author(s):
Metcalf, Harold, author
Fiske, A. H., author
Publication:
London : Combined Intelligence Objectives Sub-Committee, [1945]
Subject(s):
Drug Industry
Technology, Pharmaceutical
World War II
Germany
Nordmark-Werke GmbH.
Interessengemeinschaft Farbenindustrie Aktiengesellschaft.
Behringwerke AG.
E. Merck (Firm)

22. Pharmaceuticals and insecticides at the I.G. Farbenindustrie plant Höchst A. Main, 10-11 April 1945

Author(s):
Horack, Harold Maclachlan, 1912-1977, author
Leaper, Percy J., author
Smadel, Joseph E. (Joseph Edwin), 1907-1963, author
Volwiler, Ernest H., 1893-1992, author
Publication:
[London] : Combined Intelligence Objectives Sub-Committee, G-2 Division, SHAEF (Rear) APO 413, [1945]
Subject(s):
Drug Industry
Chemical Industry
Pharmaceutical Preparations
Insecticides
World War II
Germany
Interessengemeinschaft Farbenindustrie Aktiengesellschaft.

24. 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.

25. 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.

41. 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.

44. 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.

45. 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.

48. 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

49. Remote interactive evaluations of drug manufacturing and bioresearch monitoring facilities during the COVID-19 public health emergency

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, April 2021
Subject(s):
Consumer Product Safety
Drug Industry
Pharmaceutical Research
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

59. Opioid crisis

Author(s):
Berry, Melissa D., author
Publication:
[Toronto, Ontario] : Thomson Reuters, 23-December-2019
Subject(s):
Health Care Reform -- legislation & jurisprudence
Opioid-Related Disorders -- epidemiology
Opioid-Related Disorders -- therapy
Commerce
Criminal Law
Drug Industry
Federal Government
Fentanyl
Fraud
Health Services Accessibility
Internet
Inappropriate Prescribing
Liability, Legal
Naloxone
Narcotic Antagonists
Opiate Substitution Treatment
State Government
Humans
China
United States

60. Cost savings

Author(s):
Steiner, David J., author
Publication:
[Toronto, Ontario] : Thomson Reuters, 23-December-2019
Subject(s):
Cost Control -- legislation & jurisprudence
Cost Savings
Drug Costs -- legislation & jurisprudence
Economics, Pharmaceutical
Legislation, Drug
Access to Information
Biosimilar Pharmaceuticals
Commerce
Conflict of Interest
Drug Industry
Insurance, Pharmaceutical Services
Managed Care Programs
Medicaid -- economics
Medicare Part D -- economics
Patents as Topic
State Government
Humans
United States

61. Coordinated development of antimicrobial drugs and antimicrobial susceptibility test devices: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, February 1, 2019
Subject(s):
Anti-Infective Agents
Device Approval
Drug Approval
Drug Development
Microbial Sensitivity Tests
Drug Industry
Biotechnology
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

62. Testing of glycerin, propylene glycol, maltitol solution, hydrogenated starch hydrolysate, sorbitol solution, and other high-risk drug components for diethylene glycol and ethylene glycol: guidance for industry

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, May 2023
Subject(s):
Drug Contamination
Drug Industry
Drug-Related Side Effects and Adverse Reactions
Ethylene Glycols
Glycerol
Government Regulation
Propylene Glycol
Sorbitol
United States

67. Compounding certain ibuprofen oral suspension products under section 503B of the Federal Food, Drug, and Cosmetic Act

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, April 2023
Subject(s):
Administration, Oral
Drug Compounding -- methods
Drug Compounding -- standards
Drug Industry
Government Regulation
Ibuprofen
Legislation, Drug
Suspensions
United States
United States. Food and Drug Administration
United States.

74. Presenting quantitative efficacy and risk information in direct-to-consumer (DTC) promotional labeling and advertisements: guidance for industry

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, June 2023
Subject(s):
Direct-to-Consumer Advertising -- legislation & jurisprudence
Direct-to-Consumer Advertising -- standards
Disclosure
Drug Industry
Drug Labeling -- legislation & jurisprudence
Drug Labeling -- standards
Government Regulation
United States

77. M7(R2) assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk: guidance for industry

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, July 2023
Subject(s):
Carcinogens
Drug Contamination -- prevention & control
Drug Development
Drug Industry
Government Regulation
Mutagenicity Tests
Mutagens
United States
United States. Food and Drug Administration

80. Institutional review board (IRB) review of individual patient expanded access submissions for investigational drugs and biological products: guidance for IRBs and clinical investigators

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 2023
Subject(s):
Biological Products
Compassionate Use Trials
Drug Industry
Drugs, Investigational
Ethics Committees, Research
Government Regulation
United States

85. Considerations for the use of real-world data and real-world evidence to support regulatory decision-making for drug and biological products: guidance for industry

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, August 2023
Subject(s):
Biological Products
Clinical Trials as Topic
Data Analysis
Decision Making
Drug Approval
Drug Industry
Drug and Narcotic Control
Government Regulation
United States
United States.

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

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, August 2023
Subject(s):
Counterfeit Drugs
Drug Industry
Drug and Narcotic Control
Fraud
Government Regulation
Substandard Drugs
United States
United States.

87. Voluntary consensus standards recognition program for regenerative medicine therapies: guidance for industry

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, October 2023
Subject(s):
Drug Industry
Government Regulation
Reference Standards
Regenerative Medicine -- legislation & jurisprudence
Regenerative Medicine -- standards
Voluntary Programs
United States
Center for Biologics Evaluation and Research (U.S.)

91. Human prescription drug and biological products: labeling for dosing based on weight or body surface area for ready-to-use containers : “dose banding” : guidance for industry

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, October 2023
Subject(s):
Biological Products -- administration & dosage
Drug Dosage Calculations
Drug Industry
Drug Labeling
Drug Packaging
Government Regulation
Injections -- standards
Prescription Drugs -- administration & dosage
Product Labeling
Product Packaging
United States

97. Direct-to-consumer prescription drug advertisements: presentation of the major statement in a clear, conspicuous, and neutral manner in advertisements in television and radio format final rule : questions and answers : guidance for industry

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, December 2023
Subject(s):
Direct-to-Consumer Advertising -- legislation & jurisprudence
Drug Industry
Government Regulation
Legislation, Drug
Prescription Drugs
United States

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