NLM Digital Collections

Search

Start Over Genre Guideline ✖Remove constraint Genre: Guideline Dates by Range 2000 and later ✖Remove constraint Dates by Range: 2000 and later

2. Acne vulgaris: establishing effectiveness of drugs intended for treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):
Acne Vulgaris -- drug therapy
Drug Evaluation -- standards
Clinical Trials as Topic -- standards
Endpoint Determination
Research Design -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6. Administrative procedures for CLIA categorization: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, October 2, 2017
Subject(s):
Clinical Laboratory Techniques
Device Approval -- standards
Diagnostic Test Approval -- standards
In Vitro Techniques -- standards
Reagent Kits, Diagnostic -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

7. Advancement of emerging technology applications for pharmaceutical innovation and modernization

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 2017
Subject(s):
Biomedical Technology -- standards
Drug Industry -- standards
Inventions
Quality Assurance, Health Care
Quality Improvement
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

8. Allergic rhinitis: developing drug products for treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 2018
Subject(s):
Clinical Trials as Topic
Drug Evaluation
Rhinitis, Allergic -- drug therapy
Adrenal Cortex Hormones -- therapeutic use
Adult
Child
Drug Combinations
Research Design
Single-Blind Method
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

9. Alternative procedures for the manufacture of cold-stored platelets intended for the treatment of active bleeding when conventional platelets are not available or their use is not practical: guidance for industry

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, June 2023
Subject(s):
Biological Products -- standards
Blood Platelets
Government Regulation
Platelet Transfusion
Refrigeration
United States

11. Anthrax: developing drugs for prophylaxis of inhalational anthrax

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):
Anthrax -- drug therapy
Anthrax -- prevention & control
Antibiotic Prophylaxis
Clinical Trials as Topic
Drug Evaluation, Preclinical -- standards
Drugs, Investigational -- therapeutic use
Inhalation Exposure
Adult
Child
Endpoint Determination
Microbial Sensitivity Tests -- standards
Pediatrics
Product Surveillance, Postmarketing -- standards
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

12. 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.

16. Appropriate use of voluntary consensus standards in premarket submissions for medical devices: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 14, 2018
Subject(s):
Clinical Trials as Topic
Consensus
Device Approval
Equipment and Supplies -- standards
Voluntary Programs
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

19. Assessing user fees under the Prescription Drug User Fee Amendments of 2017

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):
Fees and Charges
Investigational New Drug Application -- economics
Prescription Drugs -- economics
Biological Products -- economics
Orphan Drug Production -- economics
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

20. Assessing user fees under the biosimilar user fee amendments of 2017

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, June 2018
Subject(s):
Biosimilar Pharmaceuticals -- economics
Fees and Charges
Investigational New Drug Application -- economics
Drug Evaluation -- economics
Parenteral Nutrition Solutions -- economics
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

21. BCG-unresponsive nonmuscle invasive bladder cancer: developing drugs and biologics for treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, February 2018
Subject(s):
Clinical Trials as Topic -- standards
Drug Evaluation -- standards
Urinary Bladder Neoplasms -- drug therapy
Biological Products -- therapeutic use
Chemistry, Pharmaceutical
Mycobacterium bovis
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

23. 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.

25. Bioanalytical method validation

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):
Drug Evaluation, Preclinical -- standards
Reproducibility of Results
Research Design -- standards
Validation Studies as Topic
Biomarkers
Documentation
Dried Blood Spot Testing -- standards
Investigational New Drug Application
Quality Control
Reagent Kits, Diagnostic -- standards
Sensitivity and Specificity
Specimen Handling -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

33. Center for Devices and Radiological Health appeals processes: questions and answers about 517A : guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, Maryland] : Center for Devices and Radiological Health, September 29, 2017
Subject(s):
Device Approval -- standards
Documentation -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

34. Chronic hepatitis C virus infection: developing direct-acting antiviral drugs for treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, November 2017
Subject(s):
Antiviral Agents -- therapeutic use
Clinical Trials as Topic
Drug Evaluation, Preclinical -- standards
Drugs, Investigational -- therapeutic use
Hepatitis C, Chronic -- drug therapy
Antiviral Agents -- pharmacokinetics
Drugs, Investigational -- pharmacokinetics
Research Design -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

35. Chronic obstructive pulmonary disease: use of the St. George's Respiratory Questionnaire as a PRO assessment tool

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, March 2018
Subject(s):
Patient Outcome Assessment
Patient Reported Outcome Measures
Pulmonary Disease, Chronic Obstructive -- therapy
Surveys and Questionnaires
Clinical Trials as Topic
Outcome Assessment (Health Care)
Self-Assessment
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

37. 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.

38. Classification of products as drugs and devices & additional product classification issues: final guidance : guidance for industry and FDA staff

Publication:
Silver Spring, MD : Office of Combination Products, Food and Drug Administration, September 2017
Subject(s):
Biological Products -- classification
Classification -- methods
Equipment and Supplies -- classification
Pharmaceutical Preparations -- classification
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

41. Clinical trial imaging endpoint process standards

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, April 2018
Subject(s):
Clinical Trials as Topic -- standards
Diagnostic Imaging -- standards
Endpoint Determination -- standards
Research Design -- standards
Observer Variation
Single-Blind Method
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

44. Compliance policy for required warning statements on small-packaged cigars

Publication:
Silver Spring, MD : Center for Tobacco Products, Food and Drug Administration, September 2017
Subject(s):
Product Labeling -- standards
Product Packaging -- standards
Tobacco Products -- standards
Guideline Adherence
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

45. Compliance policy regarding blood and blood component donation suitability, donor eligibility and source plasma quarantine hold requirements: guidance for industry

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, October 2023
Subject(s):
Blood Banking -- standards
Blood Donation -- standards
Blood Donors
Donor Selection -- standards
Government Regulation
Guideline Adherence
Plasma
United States

46. Complicated intra-abdominal infections: developing drugs for treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):
Anti-Bacterial Agents -- therapeutic use
Clinical Trials as Topic
Drug Evaluation -- standards
Drugs, Investigational -- pharmacokinetics
Intraabdominal Infections -- drug therapy
Microbiological Techniques -- standards
Drug Labeling -- standards
Endpoint Determination -- standards
Research Design -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

47. Complicated urinary tract infections: developing drugs for treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, June 2018
Subject(s):
Anti-Bacterial Agents -- therapeutic use
Anti-Infective Agents, Urinary -- therapeutic use
Clinical Trials as Topic -- standards
Drug Evaluation
Microbiological Techniques -- standards
Urinary Tract Infections -- drug therapy
Endpoint Determination -- standards
Research Design -- standards
Urinary Tract Infections -- complications
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

51. 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.

52. Computer-assisted detection devices applied to radiology images and radiology device data: premarket notification [510(k)] submissions : guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, September 28, 2022
Subject(s):
Diagnosis, Computer-Assisted
Device Approval
Government Regulation
Radiographic Image Interpretation, Computer-Assisted
United States
United States. Food and Drug Administration

53. Considerations for design, development, and analytical validation of next generation sequencing (NGS)--based in vitro diagnostics (IVDs) intended to aid in the diagnosis of suspected germline diseases: guidance for stakeholders and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, April 13, 2018
Subject(s):
Genetic Testing
Germ-Line Mutation
Diagnostic Test Approval
Reagent Kits, Diagnostic -- standards
Sequence Analysis, DNA
Genomics
Reproducibility of Results
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

55. 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.

56. Consumer antiseptic wash final rule: questions and answers : (Small Entity Compliance Guide)

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, July 2017
Subject(s):
Anti-Infective Agents, Local
Consumer Product Safety
Hand Sanitizers
Nonprescription Drugs
Anti-Bacterial Agents
Anti-Infective Agents, Local -- adverse effects
Soaps
Triclosan
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

61. Cybersecurity in medical devices: refuse to accept policy for cyber devices and related systems under section 524B of the FD&C Act : guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, March 30, 2023
Subject(s):
Computer Security -- legislation & jurisprudence
Device Approval
Equipment Safety
Government Regulation
United States
United States.

63. De novo classification process (evaluation of automatic class III designation): guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, October 30, 2017
Subject(s):
Classification
Device Approval -- standards
Equipment and Supplies -- classification
Equipment Safety -- classification
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

64. Deciding when to submit a 510(k) for a change to an existing device: guidance for Industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, October 25, 2017
Subject(s):
Device Approval -- standards
Equipment Design -- standards
Equipment Safety -- standards
Product Labeling -- standards
Reagent Kits, Diagnostic -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

65. Deciding when to submit a 510(k) for a software change to an existing device: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, October 25, 2017
Subject(s):
Device Approval -- standards
Software -- standards
Computer Security
Equipment Design -- standards
Equipment Safety -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

68. Design considerations and pre-market submission recommendations for interoperable medical devices: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, September 6, 2017
Subject(s):
Equipment and Supplies -- standards
Equipment Design -- standards
Equipment Safety -- standards
Device Approval
Equipment Failure
Information Dissemination
Risk Management
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

69. Developing and responding to deficiencies in accordance with the least burdensome provisions: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, September 29, 2017
Subject(s):
Device Approval -- standards
Communication
Documentation -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

76. 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

77. Display devices for diagnostic radiology: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, October 2, 2017
Subject(s):
Data Display -- standards
Image Processing, Computer-Assisted -- standards
Radiology Information Systems -- standards
Device Approval -- standards
Product Labeling -- standards
Software -- standards
Technology, Radiologic -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

78. Dissolution testing and acceptance criteria for immediate-release solid oral dosage form drug products containing high solubility drug substances

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, August 2018
Subject(s):
Chemistry, Pharmaceutical
Drug Liberation
Solubility
Dosage Forms
Therapeutic Index, Drug
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

79. 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.

81. Duchenne muscular dystrophy and related dystrophinopathies: developing drugs for treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, February 2018
Subject(s):
Clinical Trials as Topic -- standards
Drug Evaluation -- standards
Muscular Dystrophies -- drug therapy
Muscular Dystrophy, Duchenne -- drug therapy
Drug Labeling -- standards
Drugs, Investigational
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

82. E11(R1) addendum: clinical investigation of medicinal products in the pediatric population

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, April 2018
Subject(s):
Clinical Trials as Topic -- ethics
Drug Compounding -- standards
Pediatrics
Pharmaceutical Preparations
Child
Excipients
Infant
Infant, Newborn
International Cooperation
Models, Theoretical
Pharmaceutical Preparations -- administration & dosage
Taste
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

84. 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.

86. E18 genomic sampling and management of genomic data

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, March 2018
Subject(s):
Data Collection -- standards
Genomics -- standards
Specimen Handling -- standards
Confidentiality
Genetic Testing
Genotyping Techniques
Information Management -- standards
Informed Consent
International Cooperation
Privacy
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

88. E6(R2) good clinical practice: integrated addendum to ICH E6(R1)

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, March 2018
Subject(s):
Clinical Trials as Topic -- ethics
Clinical Trials as Topic -- methods
Ethics Committees, Research
Informed Consent
Randomized Controlled Trials as Topic -- ethics
Randomized Controlled Trials as Topic -- methods
Research Design
Research Subjects
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

92. 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.

95. Enforcement policy for face masks and barrier face coverings during the coronavirus disease (COVID-19) public health emergency: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, March 13, 2023
Subject(s):
COVID-19 -- prevention & control
Government Regulation
Masks -- standards
Medical Device Legislation
Personal Protective Equipment
United States
United States. Food and Drug Administration

96. Enforcement policy for face shields, surgical masks, and respirators during the coronavirus disease (COVID-19) public health emergency: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, March 13, 2023
Subject(s):
COVID-19 -- prevention & control
Government Regulation
Masks -- standards
Medical Device Legislation
N95 Respirators -- standards
Personal Protective Equipment
Respiratory Protective Devices -- standards
United States
United States. Food and Drug Administration

100. Establishing effectiveness for drugs intended to treat male hypogonadotropic hypogonadism attributed to nonstructural disorders

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):
Clinical Trials as Topic -- standards
Drug Evaluation -- standards
Endpoint Determination
Hypogonadism -- drug therapy
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.