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Responsibility for IRB Compliance

“Institution” Responsibility: Antibody Systems Inc. Citizen Petition

  • FDA inspection revealed that IRB was out of compliance with IRB regulations

  • FDA sent Warning Letter to IRB’s “parent institution” — the entity that established the IRB, in this case, Antibody Systems Inc. (ASI)

  • ASI and its president filed a citizen petition objecting

  • FDA denied the petition on the ground that 21 CFR 56.120(c) gives FDA discretion to take action against the IRB or the parent, depending on their level of responsibility (Docket FDA-2005-P-0253 on regulations.gov)

  • FDA found that the company was directly involved in the IRB’s actions

  • Demonstrates FDA’s new willingness to look behind contractual and

corporate arrangements

© 2009 Hogan & Hartson LLP. All rights reserved.

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