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| REGULATORY GUIDELINES |
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Information regarding requesting and preparing for formal meetings with the FDA Additional information regarding the scheduling and conduct of formal meetings Information on Submitting an Investigational New Drug Application (IND) for a Biological Product: http://www.fda.gov/cber/ind/ind.htm This link includes the following applicable regulations and more.
Human Subject Protection – Information for Institutional Review Boards, Clinical Investigators, and Sponsors HHS Policy for Protection of Human Subjects Human Participant Protections Education for Research Teams List of guidance documents related to submission of INDs FDA Regulations Relating to Good Clinical Practice and Clinical Trials FDA regulations on the exportation of investigational new drugs, including biological products Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees Final Rule: Investigational New Drug Safety Reporting Requirement for Human Drug and Biological Products and Safety Reporting Requirement for Bioavailability and Bioequivalence Studies in Human General information regarding the FDA regulation of Cellular and Gene Therapies Regulatory Process for the Office of Cellular, Tissue and Gene Therapies (OCTGT) FDA Expectations for INDs for Cellular and Gene Therapy Gene Therapy Clinical Trials Observing Subjects for Delayed Adverse Events NIH guidelines for research involving recombinant DNA molecules (NIH guidelines)
October 2011 Compliance with the NIH Guidelines for Research Involving Recombinant DNA Molecules Office of Biotechnology Activities (OBA) home page Recombinant DNA Advisory Committee (RAC) webpage Role of the Recombinant DNA Advisory Committee (RAC) and the Protocol Review Process Institutional Biosafety Committee (IBC) webpage Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy Policies and Regulations regarding Laboratory Animal Welfare Information Resources for Institutional Animal Care and Use Committee (IACUC)
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| Investigator Registration | Request for Service Application | Core Laboratories | Scientific Review Board | Steering Committee | NHLBI Gene Therapy Group |