Clinical Trial Regulations – FDA publishes FAQ on IRB registration
the FDA publishes FAQ – Guidance for Institutional Review Boards (IRBs) Frequently Asked Questions – IRB Registration This guidance is intended to assist institutional review boards (IRBs) in complying with the new requirement for IRB registration. This requirement is an amendment to Part 56, Institutional Review Boards, (21 CFR 56.106), that requires each IRB in the United States (U.S.) that reviews FDA-regulated studies to register. IRB registration information is entered into an Internet-based registration system maintained by the Department of Health and Human Services (HHS). This system is a modification of the one used by the Office for Human Research Protections (OHRP) for registration of IRBs that are designated by institutions under Federalwide Assurances (FWAs). OHRP has issued a similar rule requiring IRBs designed under FWAs to register or update their registration information at this modified site. (See 74 FR 2399 (Jan. 15, 2009))
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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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