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Regulations: Good Clinical Practice and Clinical Trials
- https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/regulations-good-clinical-practice-and-clinical-trials
- Here are links to FDA regulations governing human subject protection and the conduct of clinical trials. Electronic Records; Electronic Signatures (21 CFR Part 11) Regulatory Hearing Before the...
Clinical Trials Guidance Documents | FDA
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-trials-guidance-documents
- Jan 31, 2023
Clinical Trials and Human Subject Protection | FDA
- https://www.fda.gov/science-research/science-and-research-special-topics/clinical-trials-and-human-subject-protection
- FDA’s regulations and guidances for clinical trials help support efficient medical product development, while assuring trials generate the robust evidence needed …
FDA Takes Steps to Further Harmonize Clinical …
- https://www.fda.gov/news-events/fda-voices/fda-takes-steps-further-harmonize-clinical-research-regulations-hhs-common-rule
- Recently, the agency published two proposed rules that demonstrate the significant progress we’ve made toward harmonizing our human subject protection …
Search for FDA Guidance Documents | FDA - U.S. Food …
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents
- The table below lists all official FDA Guidance Documents and other regulatory guidance. You can search for documents using key words, and you can narrow or filter your results …
Code of Federal Regulations (CFR) | FDA
- https://www.fda.gov/medical-devices/overview-device-regulation/code-federal-regulations-cfr
- Code of Federal Regulations (CFR) | FDA Code of Federal Regulations (CFR) FDA's legal authority to regulate both medical devices and electronic radiation-emitting products is …
FDA Rules and Regulations | FDA - U.S. Food and Drug …
- https://www.fda.gov/regulatory-information/fda-rules-and-regulations
- Review of Proposed and Final Rules Related Resources As required by law, the Food and Drug Administration publishes regulations in the Federal Register, the …
CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=58.190
- Sec. 58.190 Storage and retrieval of records and data. (a) All raw data, documentation, protocols, final reports, and specimens (except those specimens …
CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=50
- CFR - Code of Federal Regulations Title 21 FDA Home Medical Devices Databases The information on this page is current as of Jul 20, 2022. For the most up-to …
CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=312.32
- The sponsor must notify FDA and all participating investigators (i.e., all investigators to whom the sponsor is providing drug under its INDs or under any …
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