Subjects: Drug Approval - Digital Collections - National Library of Medicine Search Results

1. Fraud fighters

Publication:: [Culver City, CA] : RKO Pathe, c1949
Subject(s):: Drug Approval
Fraud -- prevention & control
Advertising as Topic
Product Surveillance, Postmarketing
United States. Food and Drug Administration.

2. Health document submission requirements for tobacco products: (revised)

Publication:: Silver Spring, MD : Center for Tobacco Products, October 2017
Subject(s):: Documentation -- standards
Tobacco Products -- standards
Drug Approval
Health
Terminology as Topic
Tobacco Products -- adverse effects
Tobacco Products -- toxicity
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

3. Q11 development and manufacture of drug substances (chemical entities and biotechnological/biological entities): questions and answers

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, February 2018
Subject(s):: Chemistry, Pharmaceutical -- standards
Pharmaceutical Preparations -- standards
Biological Products -- standards
Congresses as Topic
Drug Approval
Drug Contamination
International Cooperation
Quality Control
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4. Special protocol assessment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2018
Subject(s):: Clinical Protocols -- standards
Clinical Trials as Topic -- standards
Drug Approval
Drug Evaluation, Preclinical -- standards
Research Design
Carcinogenicity Tests -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

5. 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.

6. S9 nonclinical evaluation for anticancer pharmaceuticals: questions and answers

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2018
Subject(s):: Antineoplastic Agents -- therapeutic use
Clinical Trials as Topic
Drug Evaluation, Preclinical
Antineoplastic Agents -- toxicity
Drug Approval
Drug Contamination
Research Design
Toxicity Tests
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

7. ANDA submissions--amendments to abbreviated new drug applications under GDUFA

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2018
Subject(s):: Drugs, Generic -- standards
Investigational New Drug Application
Drug Approval
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

8. Clarification of orphan designation of drugs and biologics for pediatric subpopulations of common diseases

Publication:: Silver Spring, MD : Office of Orphan Products Development, Food and Drug Administration, July 2018
Subject(s):: Drug Approval
Orphan Drug Production
Pediatrics
Adolescent
Biological Products
Child
Clinical Trials as Topic
Colitis, Ulcerative -- drug therapy
HIV Infections -- drug therapy
Infant
Prevalence
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

9. Quality attribute considerations for chewable tablets

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2018
Subject(s):: Chemistry, Pharmaceutical
Drug Liberation
Mastication
Quality Control
Solubility
Tablets -- pharmacokinetics
Drug Approval
Drug Labeling
Hardness
Therapeutic Equivalency
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

10. A most excellent cure for the stone and gravel

Author(s):: Stephens, Joanna, -1774
Publication:: London : Printed for the benefit of mankind in general, [1740?]
Subject(s):: Calculi -- therapy
Materia Medica
Drug Approval
England

11. Emergency use authorization of medical products and related authorities: guidance for industry and other stakeholders

Publication:: Silver Spring, MD : Food and Drug Administration, U.S. Department of Health and Human Services, January 2017
Subject(s):: Civil Defense -- legislation & jurisprudence
Device Approval
Drug Approval
Emergencies
Terrorism
Emergency Medical Services
Equipment Safety
Off-Label Use
Public Health
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Department of Homeland Security.
United States. Food and Drug Administration.

12. Form FDA 3674--certifications to accompany drug, biological product, and device applications/submissions: guidance for sponsors, industry, researchers, investigators, and food and drug administration staff

Publication:: Silver Spring, MD : Food and Drug Administration, U.S. Department of Health and Human Services, June 2017
Subject(s):: Device Approval
Drug Approval
Investigational New Drug Application
Access to Information
Clinical Trials as Topic
Drugs, Investigational
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

13. E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs--questions and answers (R3)

14. M4E(R2): the CTD--efficacy

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2017
Subject(s):: Drug Approval
Investigational New Drug Application
Drugs, Investigational
Clinical Trials as Topic
Congresses as Topic
International Cooperation
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

15. Generic Drug User Fee Amendments of 2012: questions and answers related to self-identification of facilities, review of generic drug submissions, and inspections and compliance

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2017
Subject(s):: Drug Approval
Drug Industry -- standards
Drugs, Generic
Guideline Adherence
Investigational New Drug Application
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

16. Antibacterial therapies for patients with an unmet medical need for the treatment of serious bacterial diseases

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2017
Subject(s):: Anti-Bacterial Agents -- therapeutic use
Bacterial Infections -- drug therapy
Drug Approval
Drug Resistance, Bacterial
Investigational New Drug Application
Clinical Trials as Topic
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

17. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 1(R1) : residue on ignition/sulphated ash general chapter

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2017
Subject(s):: Chemistry, Pharmaceutical
Drug Approval
Pharmacopoeias as Topic -- standards
Congresses as Topic
International Cooperation
Sulfur
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

18. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 2(R1) : test for extractable volume of parenteral preparations general chapter

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2017
Subject(s):: Chemistry, Pharmaceutical
Drug Approval
Pharmacopoeias as Topic -- standards
Congresses as Topic
Infusions, Parenteral
International Cooperation
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

19. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 3(R1) : test for particulate contamination : subvisible particles general chapter

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2017
Subject(s):: Drug Approval
Drug Contamination
Particulate Matter
Pharmacopoeias as Topic -- standards
Congresses as Topic
International Cooperation
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

20. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 4A(R1) : microbiological examination of nonsterile products : microbial enumeration tests general chapter

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2010
Subject(s):: Drug Approval
Microbiological Techniques -- standards
Pharmacopoeias as Topic -- standards
Congresses as Topic
International Cooperation
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

21. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 4B(R1) : microbiological examination of nonsterile products : tests for specified microorganisms general chapter

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2017
Subject(s):: Drug Approval
Microbiological Techniques -- standards
Pharmacopoeias as Topic -- standards
Congresses as Topic
International Cooperation
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

22. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 4C(R1) : microbiological examination of nonsterile products : acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use general chapter

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2017
Subject(s):: Drug Approval
Microbiological Techniques -- standards
Pharmacopoeias as Topic -- standards
Congresses as Topic
International Cooperation
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

23. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 5(R1) : disintegration test general chapter

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2017
Subject(s):: Chemistry, Pharmaceutical -- standards
Drug Approval
Pharmacopoeias as Topic -- standards
Capsules
Congresses as Topic
International Cooperation
Tablets
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

24. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 9(R1) : tablet friability general chapter

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2017
Subject(s):: Chemistry, Pharmaceutical -- standards
Drug Approval
Pharmacopoeias as Topic -- standards
Congresses as Topic
International Cooperation
Tablets
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

25. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 10(R1) : polyacrylamide gel electrophoresis general chapter

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2017
Subject(s):: Drug Approval
Pharmacopoeias as Topic -- standards
Congresses as Topic
Electrophoresis, Polyacrylamide Gel
International Cooperation
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

26. 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.

27. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 8 (R1) : sterility test general chapter

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2017
Subject(s):: Chemistry, Pharmaceutical -- standards
Drug Approval
Pharmacopoeias as Topic -- standards
Sterilization
Congresses as Topic
International Cooperation
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

28. M4 organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2017
Subject(s):: Documentation -- standards
Drug Approval
Congresses as Topic
European Union
International Cooperation
Pharmaceutical Preparations -- standards
Humans
Canada
Europe
Japan
Switzerland
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

29. Mixing, diluting, or repackaging biological products outside the scope of an approved biologics license application

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, January 2018
Subject(s):: Biological Products
Drug Approval
Drug Packaging
Prescription Drugs
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

30. Investigational new drugs: FDA has taken steps to improve the expanded access program but should further clarify how adverse events data are used : report to Congressional addressees

Publication:: Washington, D.C. : U.S. Government Accountability Office, July 2017
Subject(s):: Adverse Drug Reaction Reporting Systems
Drugs, Investigational -- adverse effects
Drugs, Investigational -- therapeutic use
Drug Approval
Health Services Accessibility
Humans
United States
United States. Food and Drug Administration.

31. Sunscreen: FDA reviewed applications for additional active ingredients and determined more data needed : report to Congressional committees

Publication:: Washington, DC : United States Government Accountability Office, November 2017
Subject(s):: Drug Approval
Nonprescription Drugs
Sunscreening Agents
Consumer Product Safety
Humans
United States
United States. Food and Drug Administration.

32. Generic drugs: FDA should make public its plans to issue and revise guidance on nonbiological complex drugs : report to Congressional requesters

Publication:: Washington, DC : United States Government Accountability Office, December 2017
Subject(s):: Drug Approval
Drugs, Generic
Therapeutic Equivalency
Chemistry, Pharmaceutical
Doxorubicin
Drug Development
Enoxaparin
Glatiramer Acetate
Gluconates
Propofol
Humans
United States
United States. Food and Drug Administration.

33. Biologics in perspective: the case for generic biologic drugs

Publication:: Washington, D.C. : AARP Public Policy Institute, c2009
Subject(s):: Biological Products -- economics
Drug Approval
Drugs, Generic -- economics
Chemistry, Pharmaceutical -- economics
Drug Costs
Economics, Pharmaceutical
Health Expenditures
Patents as Topic
Humans
United States

34. Understanding coverage considerations for COVID-19 vaccines and treatments

Author(s):: Beleche, Trinidad, author
Bush, Laina, author
Finegold, Kenneth, 1957- author
Manocchio, Teresa, author
Pyda, Sarada, author
Samsom, Lok Wong, author
Sommers, Benjamin D., author
Publication:: Washington, D.C. : U.S. Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, August 2022
Subject(s):: Cost Savings
COVID-19 -- economics
COVID-19 Drug Treatment
COVID-19 Vaccines -- economics
Insurance Coverage -- economics
Drug Approval
United States