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5. 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.

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 Antibiotics: FDA has encouraged development, but needs to clarify the role of draft guidance and develop qualified infectious disease product guidance : report to Congressional requesters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

11. 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.

12. COVID-19: federal efforts accelerate vaccine and therapeutic development, but more transparency needed on emergency use authorizations : report to Congressional addressees

Publication:
Washington, DC : United States Government Accountability Office, November 2020
Subject(s):
COVID-19 Vaccines
Drug Approval
Drug Development
Disclosure
United States
United States. Department of Defense
United States. Department of Health and Human Services

15. 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.

19. Conduct of clinical trials of medical products during the COVID-19 public health emergency: guidance for industry, investigators, and institutional review boards

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, August 30, 2021
Subject(s):
Clinical Trials as Topic
Device Approval
Drug Approval
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

20. Considerations for the development of dried plasma products intended for transfusion

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, December 2019
Subject(s):
Blood Transfusion -- standards
Device Approval
Drug Approval
Drug Development -- standards
Plasma
Plasma -- microbiology
Product Packaging
Quality Control
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

21. 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.

22. 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.

28. 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.

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

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, June 2017
Subject(s):
Arrhythmias, Cardiac -- chemically induced
Arrhythmias, Cardiac -- diagnosis
Cardiac Electrophysiology -- methods
Cardiac Electrophysiology -- standards
Drug Approval
Electrocardiography -- standards
Long QT Syndrome -- chemically induced
Cardiotoxins
Clinical Trials as Topic
Congresses as Topic
Diagnosis, Computer-Assisted
Drug-Related Side Effects and Adverse Reactions
International Cooperation
Pharmaceutical Preparations -- administration & dosage
Reference Standards
Research Design
Sex Factors
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

32. 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.

33. Evaluation of devices used with regenerative medicine advanced therapies

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, February 2019
Subject(s):
Device Approval
Equipment and Supplies -- classification
Regenerative Medicine -- classification
Regenerative Medicine -- instrumentation
Biological Products -- classification
Cell- and Tissue-Based Therapy -- classification
Drug Approval
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

34. Evaluation of internal standard responses during chromatographic bioanalysis: questions and answers

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 2019
Subject(s):
Chromatography -- standards
Drug Approval
Quality Control
Reference Standards
Calibration
Chemistry Techniques, Analytical
Investigational New Drug Application
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

38. 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.

41. 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.

42. 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.

43. 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.

44. Hematologic malignancies: regulatory considerations for use of minimal residual disease in development of drug and biological products for treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, January 2020
Subject(s):
Biomarkers
Clinical Trials as Topic
Drug Approval
Drug Development
Drugs, Investigational
Hematologic Neoplasms -- drug therapy
Investigational New Drug Application
Neoplasm, Residual
Endpoint Determination
Leukemia, Lymphocytic, Chronic, B-Cell -- drug therapy
Leukemia, Myelogenous, Chronic, BCR-ABL Positive -- drug therapy
Leukemia, Myeloid, Acute -- drug therapy
Leukemia, Promyelocytic, Acute -- drug therapy
Multiple Myeloma -- drug therapy
Patient Selection
Precursor Cell Lymphoblastic Leukemia-Lymphoma -- drug therapy
Prognosis
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

45. Investigational in vitro diagnostics in oncology trials: streamlined submission process for study risk determination

Publication:
Silver Spring, MD : Food and Drug Administration, Oncology Center of Excellence, October 2019
Subject(s):
Clinical Trials as Topic
Device Approval
Drug Approval
Investigational New Drug Application
Medical Oncology
Reagent Kits, Diagnostic -- standards
Drugs, Investigational
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

46. 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.

48. 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.

50. Maximal usage trials for topically applied active ingredients being considered for inclusion in an over-the -counter monograph: study elements and considerations

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, May 2019
Subject(s):
Administration, Topical
Drug Approval
Nonprescription Drugs
Absorption, Physiological
Clinical Trials as Topic
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

56. One percent of drugs with Medicaid reimbursement were not FDA-approved

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, May 2019
Subject(s):
Drug Approval
Insurance, Health, Reimbursement -- economics
Insurance, Health, Reimbursement -- statistics & numerical data
Medicaid -- economics
Medicaid -- statistics & numerical data
Economics, Pharmaceutical
Fraud -- prevention & control
Prescription Drugs -- economics
Humans
United States
United States. Food and Drug Administration.

64. Providing regulatory submissions in electronic and non-electronic format: promotional labeling and advertising materials for human prescription drugs

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, April 2022
Subject(s):
Advertising -- legislation & jurisprudence
Advertising -- standards
Drug Approval
Drug Labeling -- legislation & jurisprudence
Drug Labeling -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

69. 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.

70. 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.

71. 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.

72. 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.

73. 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.

74. 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.

75. 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.

76. 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.

77. 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.

78. 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.

79. 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.

81. 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.

85. 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

88. 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.

91. Standards development and the use of standards in regulatory submissions reviewed in the Center for Biologics Evaluation and Research

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, March 2019
Subject(s):
Guidelines as Topic
Consensus
Device Approval
Drug Approval
Government Agencies
Voluntary Programs
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
Center for Biologics Evaluation and Research (U.S.)

93. 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