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Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers; Draft Guidance for Industry
CDER/CBER/CDRH/CFSAN/CTP/CVM/ORA/OCLiP, March 2023
Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment; Draft Guidance for Industry
CDER/CBER, February 2023
Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development; Draft Guidance for Industry
OPT/CDER/CBER/CDRH, February 2023
Cross Labeling Oncology Drugs in Combination Regimens; Guidance for Industry
CDER/CBER/OCE, November 2022
Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials; Draft Guidance for Industry
CDER/CBER, November 2022
Ethical Considerations for Clinical Investigations of Medical Products Involving Children; Draft Guidance for Industry, Sponsors, and IRBs
OPT/CDER/CBER/CDRH, September 2022
Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development; Draft Guidance for Industry
CDER/CBER/CDRH/OCE, May 2022
Crohn’s Disease: Developing Drugs for Treatment; Draft Guidance for Industry
CDER/CBER, April 2022
Ulcerative Colitis: Developing Drugs for Treatment; Draft Guidance for Industry
CDER/CBER, April 2022
Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet; Draft Guidance for Industry
CDER/CBER, April 2022
E8(R1) General Considerations for Clinical Sutdies; Guidance for Industry
CDER/CBER, April 2022
Inclusion of Older Adults in Cancer Clinical Trials
CDER/CBER/OCE, March 2022
Population Pharmacokinetics; Guidance for Industry
CDER/CBER, February 2022
Clinical Pharmacology Considerations for Antibody-Drug Conjugates; Draft Guidance for Industry
CDER/CBER, February 2022
Digital Health Technologies for Remote Data Acquisition in Clinical Investigations – Guidance for Industry, Investigators, and Other Stakeholders; Draft Guidance for Industry
CDER/CBER/CDRH/OCE, December 2021
Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment; Draft Guidance for Industry
CDER/CBER, December 2021
Development of Anti-Infective Drug Products for the Pediatric Population; Guidance for Industry
CDER/CBER, December 2021
Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry
CDER/CBER, December 2021
Benefit-Risk Assessment for New Drug and Biological Products; Draft Guidance for Industry
CDER/CBER, September 2021
Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry
CDER/CBER/OCE, September 2021
Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency; Guidance for Industry, Investigators, and Institutional Review Boards
CDER/CBER/CDRH/OC, August 2021
Nonmetastatic Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials; Guidance for Industry
CDER/CBER, August 2021
Evaluating Cancer Drugs in Patients with Central Nervous System Metastases; Guidance for Industry
OCE/CDER/CBER, July 2021
Cancer Clinical Trial Eligibility Criteria: Approach to Available Therapy in Non-Curative Settings; Draft Guidance for Industry
OCE/CDER/CBER, June 2021
Premenopausal Women with Breast Cancer: Developing Drugs for Treatment; Guidance for Industry
OCE/CDER/CBER, June 2021
Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products; Guidance for Industry
CBER/CDER, December 2020
Cross Labeling Oncology Drugs in Combination Regimens; Draft Guidance for Industry
OCE/CDER/CBER, November 2020
Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs; Guidance for Industry
CDER/CBER, November 2020
Development of Anti-Infective Drug Products for the Pediatric Population; Draft Guidance for Industry
CDER/CBER, June 2020
Risk Evaluation and Mitigation Strategies: Modifications and Revisions; Guidance for Industry
CDER/CBER, June 2020
Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics; Draft Guidance for Industry
CDER/CBER, February 2020
Mucopolysaccharidosis Type III (Sanfilippo Syndrome): Developing Drugs for Treatment; Draft Guidance for Industry
CDER/CBER, February 2020
Bridging for Drug-Device and Biologic-Device Combination Products; Draft Guidance for Industry
OCE/CDER/CBER, January 2020
Adaptive Design Clinical Trials for Drugs and Biologics; Guidance for Industry
CDER/CBER, November 2019
Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment Guidance for Industry; Guidance for Industry
CDER/CBER, September 2019
Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products; Guidance for Industry
CDER/CBER, August 2019
Fabry Disease: Developing Drugs for Treatment; Draft Guidance for Industry
CDER/CBER, August 2019
Bacterial Vaginosis: Developing Drugs for Treatment; Guidance for Industry
CDER/CBER, August 2019
Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention; Guidance for Industry
CDER/CBER, July 2019
Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations; Guidance for Industry
CDER/CBER, June 2019
Treatment for Heart Failure: Endpoints for Drug Development; Draft Guidance for Industry
CDER/CBER, June 2019
Postapproval Pregnancy Safety Studies ; Draft Guidance for Industry
CDER/CBER, May 2019
Clinical Lactation Studies: Considerations for Study Design; Draft Guidance for Industry
CDER/CBER, May 2019
Rare Diseases: Natural History Studies for Drug Development; Draft Guidance for Industry
CDER/CBER/OOPD, March 2019
Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products; Guidance for Industry
CDER/CBER, March 2019
Pediatric HIV Infection: Drug Development for Treatment; Guidance for Industry
CDER/CBER, March 2019
Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials; Guidance for Industry
CDER/CBER/OCE, March 2019
Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections Guidance for Industry; Draft Guidance for Industry
OCE/CDER/CBER, March 2019
Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients Guidance for Industry; Draft Guidance for Industry
OCE/CDER/CBER, March 2019
Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies ; Draft Guidance for Industry
OCE/CDER/CBER, March 2019
Cancer Clinical Trial Eligibility Criteria: Brain Metastases; Draft Guidance for Industry
OCE/CDER/CBER, March 2019
Enrichment Strategies for Clinical Trials to Support Demonstration of Effectiveness of Human Drugs and Biological Products; Guidance for Industry
CDER/CBER, March 2019
Pediatric HIV Infection: Drug Development for Treatment; Draft Guidance for Industry
CDER/CBER, March 2019
Rare Diseases: Common Issues in Drug Development; Guidance for Industry
CDER/CBER, February 2019
Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
OCE/CDER/CBER, December 2018
Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials; Draft Guidance for Industry
CDER/CBER, November 2018
Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs; Guidance for Industry
CDER/CBER, October 2018
Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development; Draft Guidance for Industry
CDER/CBER, August 2018
Osteoarthritis: Structural Endpoints for the Development of Drugs; Draft Guidance for Industry
CDER/CBER/CDRH, August 2018
Use of Electronic Health Record Data in Clinical Investigations; Guidance for Industry
CDER/CBER/CDRH, July 2018
Clinical Trial Imaging Endpoint Process Standards; Guidance for Industry
CDER/CBER, April 2018
Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials; Draft Guidance for Industry
CDER/CBER, April 2018
BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment; Guidance for Industry
CDER/CBER, February 2018
Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers
OHRP/CDER/OGCP/CBER/CDRH, December 2016
Non-Inferiority Clinical Trials to Establish Effectiveness; Guidance for Industry
CDER/CBER, November 2016
Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development
CDRH, CDER, CBER, OMPT, February 2016
Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations
CDER/CBER, February 2016
Product Development Under the Animal Rule; Guidance for Industry
CDER/CBER, October 2015
Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics
CDER/CBER, April 2015
Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff – FDA Decisions for Investigational Device Exemption Clinical Investigations
CDRH/CBER, August 2014
Informed Consent Information Sheet; Draft Guidance for IRBs, Clinical Investigators, and Sponsors
CDER/CBER/CDRH, July 2014
Premarket Assessment of Pediatric Medical Devices; Guidance for Industry and FDA Staff
CDRH/CBER, March 2014
Annual Reports for Approved Premarket Approval Applications (PMA); Guidance for Industry and FDA Staff
CDRH/CBER, February 2014
Investigational New Drug Applications (INDs)-Determining Whether Human Research Studies Can Be Conducted Without an IND; Guidance for Clinical Investigators, Sponsors, and IRBs
CDER/CBER, September 2013
Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets; Guidance for Industry and FDA Staff
CDER/CBER, May 2013
M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals – Questions and Answers; Guidance for Industry
CDER/CBER, February 2013
Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling; Guidance for Industry
CDER/CBER/CDRH, January 2013
FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND: Frequently Asked Questions; Guidance for Industry and FDA Staff
CDER/CBER, March 2012
The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application; Guidance for Industry and Researchers
CDER/CBER, August 2010
Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials
CDRH/CBER, February 2010
M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals; Guidance for Industry
CDER/CBER, January 2010
Drug-Induced Liver Injury: Premarketing Clinical Evaluation; Guidance for Industry
CDER/CBER, July 2009
Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs – Improving Human Subject Protection
OC/CDER/CBER/CDRH/GCPP, January 2009
Guidance for Industry and FDA Staff – Modifications to Devices Subject to Premarket Approval (PMA) – The PMA Supplement Decision-Making Process
CDRH/CBER, December 2008
Guidance for Industry: Computerized Systems Used in Clinical Investigations
FDA/OC, May 2007
Real-Time Premarket Approval Application (PMA) Supplements; Guidance for Industry and FDA Staff
CDRH/CBER, April 2006
Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products -?? Content and Format; Guidance for Industry
CDER/CBER, January 2006
Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
CDRH/CBER, May 2005
Submitting and Reviewing Complete Responses to Clinical Holds (Revised); Guidance for Industry
CDER/CBER, October 2000
Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA); Guidance for Industry
CDER/CBER/CDRH, February 1999
Population Pharmacokinetics; Guidance for Industry
CDER/CBER, February 1999
Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products; Guidance for Industry
CDER/CBER, November 1995
Fonte/Source: http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/clinical-guidances
