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FDA Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies.pdfFDA Collection-of-Race-and-Ethnicity-Data-in-Clinical-Trials final--Jan 2025 update.pdfFDA Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products.pdfFDA Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes.pdfFDA Cancer Clinical Trial Eligibility Criteria Performance Status.pdfFDA Clinical Lactation Studies Considerations for Study Design.pdfFDA Adaptive Design Clinical Trials for Drugs and Biologics Guidance for Industry.pdfFDA ata Standards for Drug and Biological Product Submissions Containing Real-World Data.pdfFDA 508 Clin Investigator Admin Actions_Disqualification_updated references-final.pdfFDA Cancer Clinical Trial Eligibility Criteria Laboratory Values.pdfFDA cct_washout_pd_and_concomitant_meds_draft_guidance_april_2024.pdfFDA 2019-89-DG- Ethical Consideratons for Clinical Investigations of Medical Products Involving Children (9-19-22).pdfFDA Adaptive-Designs-for-Medical-Device-Clinical-Studies---Guidance-for-Industry-and-Food-and-Drug-Administration-Staff.pdfFDA 2021-624_Underrepresented Populations Guidance -- Final Clean 08-07-23.pdfFDA 2021-391_imAR events oncology_October 2022_published-2.pdfFDA Adjusting-for-Covariates-FDA-Guidance_1.PDFFDA 2020-364 - CoC Cures 2012 - Final Guidance-CLEAN 11-10.pdfFDA adverse-event-reporting-to-irbs-guidance-document.pdfFDA core_patient-reported_outcomes_in_cancer_clinical_trials_508_0.pdfFDA Electronic-Source-Data-in-Clinical-Investigations.pdfFDA Early-Clinical-Trials-With-Live-Biotherapeutic-Products--Chemistry--Manufacturing--and-Control-Information--Guidance-for-Industry.pdfFDA E17-General-Principles-for-Planning-and-Design-of-Multi-Regional-Clinical-Trials.pdfFDA E11A Pediatric Extrapolation.pdfFDA E11(R1)-Addendum--Clinical-Investigation-of-Medicinal-Products-in-the-Pediatric-Population.pdfFDA E5-Ethnic-Factors-in-the-Acceptability-of-Foreign-Clinical-Data--Questions-and-Answers.pdfFDA E3-Structure-and-Content-of-Clinical-Study-Reports.pdfFDA Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.pdfFDA Development-and-Use-of-Risk-Minimization-Action-Plans-March-2005.pdfFDA Design-Considerations-for-Pivotal-Clinical-Investigations-for-Medical-Devices---Guidance-for-Industry--Clinical-Investigators--Institutional-Review-Boards-and-FDA-Staff.pdfFDA Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products.pdfFDA Data-Retention-When-Subjects-Withdraw-from-FDA-Regulated-Clinical-Trials.pdfFDA Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products.pdfFDA Considerations-When-Transferring-Clinical-Investigation-Oversight-to-Another-IRB---Printable-PDF.pdfFDA Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products.pdfFDA Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials.pdfFDA Conducting Clinical Trials With Decentralized Elements.pdfFDA Considerations for Complying With 21 CFR 211.110 .pdfFDA Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies.pdfFDA Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle.pdfFDA Guidance-Recommendations-Clinical-Data-510k.pdfFDA Individual-Patient-Expanded-Access-Applications-Form-FDA-3926.pdfFDA Humanitarian Device Exemption (HDE) Program.pdfFDA Guidance-Predetermined-Change-Control-AIML.pdfFDA Guidance-Predetermined-Change-Control-Plans.pdfFDA Financial-Disclosure-by-Clinical-Investigators.pdfFDA Emergency Use Authorization of Medical Products and Related Authorities.pdfFDA Exculpatory-Language-in-Informed-Consent---Draft-Guidance.pdfFDA Evaluation-and-Reporting-of-Age-Race-Ethnicity-Specific-Data-in-Medical-Device-Clinical-Studies-Guidance.pdfFDA Guidance-for-Industry---Using-a-Centralized-IRB-Review-Process-in-Multicenter-Clinical-Trials-(PDF).pdfFDA For Posting_HUD Guidance_Revision 1.pdfFDA Guidance-Device-Cybersecurity-Premarket.pdfFDA guidance_consent_IVD_device_human_spec_1.pdfFDA Establishment-Operation-Clinical-Trial-Data-Monitoring-Committees_Nov-2021.pdfFDA guidance-ai-enabled-device-software-functions.pdfFDA Guidance-for-Clinical-Investigators--Institutional-Review-Boards-and-Sponsors---Process-for-Handling-Referrals-to-FDA-Under-21-CFR-50.54---Additional-Safeguards-for-Children-in-Clinical-Investigations-(PDF).pdfFDA Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products.pdfFDA General_principles_on_plan_design_and_analysis_of_pharmacoepidemiological_studies_that_utilize_real-world.pdfFDA Guidance-Clinical-Decision-Software.pdfFDA Real-World Evidence Considerations Regarding Non-Interventional Studies for Drug and Biological Products.pdfFDA Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices.pdfFDA Pregnant-Women--Scientific-and-Ethical-Considerations-for-Inclusion-in-Clinical-Trials.pdfFDA Premarket Approval Application and Humanitarian Device Exemption Modular Review.pdfFDA Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring.pdfFDA Leveraging-Existing-Clinical-Data-for-Extrapolation-to-Pediatric-Uses-of-Medical-Devices---Guidance-for-Industry-and-Food-and-Drug-Administration-Staff.pdfFDA Part-11--Electronic-Records--Electronic-Signatures---Scope-and-Application-(PDF).pdfFDA master-protocols-draft-guidance-for-industry.pdfFDA Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards.pdfFDA IRB-Review-of-Stand-Alone-HIPAA-Authorizations-Under-FDA-Regulations.pdfFDA IRB-Responsibilities-for-Reviewing-the-Qualifications-of-Investigators--Adequacy-of-Research-Sites--and-the-Determination-of-Whether-an-IND-IDE-is-Needed-(Printer-Friendly).pdfFDA IRB-Continuing-Review-After-Clinical-Investigation-Approval.pdfFDA Investigator-Responsibilities-—-Protecting-the-Rights--Safety--and-Welfare-of-Study-Subjects.pdfFDA Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices.pdfFDA Investigational-New-Drug-Applications-(INDs)-Determining-Whether-Human-Research-Studies-Can-Be-Conducted-Without-an-IND.pdfFDA Investigational-IVDs-Used-in-Clinical-Investigations-of-Therapeutic-Products---Draft-Guidance-for-Industry--Food-and-Drug-Administration-Staff--Sponsors--and-Institutional-Review-Boards.pdfFDA Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice.pdfFDA Informed Consent Guidance for Institutional Review Boards Clinical Investigators and Sponsors.pdfFDA Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products.pdfFDA Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.pdfFDA Use of Data Monitoring Committees in Clinical Trials.pdfFDA Use-of-Real-World-Evidence-to-Support-Regulatory-Decision-Making-for-Medical-Devices---Guidance-for-Industry-and-Food-and-Drug-Administration-Staff.pdfFDA Real-World-Evidence-Support-Regulatory-Decision-2023.pdfFDA Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products.pdfFDA Use-of-Electronic-Health-Record-Data-in-Clinical-Investigations-Guidance-for-Industry.pdfFDA Software-as-a-Medical-Device-(SAMD)--Clinical-Evaluation---Guidance-for-Industry-and-Food-and-Drug-Administration-Staff.pdfFor publication_Neonatalguidance_7.25.22.pdf2021-629 Prior Therapy Final Guidance (for publication July 2022).pdfCDRH-Opioid-Use-Disorder-Guidance.pdfFDA-2023-D-5591-0002_attachment_1.pdfFor publication_PedsClinPharmGuidance_9.6.22.pdf55280041fnl.pdf55277950fnl (1).pdfFDA-2021-D-0789-0111_attachment_1.pdf54619456fnl_RWD Assessing Registries_Jan 2025 update.pdfFDA-IRB-DRAFTGUIDANCE_final.pdfCLIA-Waiver-Guidance.pdf2022-244 Draft_AAinOncology (March 2023).pdf54336794fnl_RWD Assessing EHRs_Jan 2025 update.pdf01 - ClinicalTrials.gov- FDA Final Guidance__2018-924_.pdf37127884dft.pdf48013335-cannabis-quality.pdf52950908dft-Psychedelic-Drugs.pdf48697696dft.pdf35593015dft-Measuring Growth Pubertal Development in Pediatric Clinical Trials.pdf00497273dft.pdfFor publication_Neonatalguidance_7.25.22.pdfFor publication_PedsClinPharmGuidance_9.6.22.pdfGuidance-DSF-MMA.pdfMultipleEndpoints_FinalGuidance.pdfevaluation_of_sex_differences_in_clinical_investigations_january_2025.pdf835.pdffinal_guidance_irb_written_procedures_may_2018_update_feb_2025_0.pdfPage updated
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