Draft Guidance On Certification Creates Ambiguity

Law360, New York (May 30, 2008, 12:00 AM EDT) -- The Public Health Service Act (PHSA) now requires that submission of certain applications pursuant to the drug, device or biologics provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA) or the PHSA be accompanied by a certification attesting that all applicable clinical trial registration and posting requirements have been met. See Section 402(j)(5)(B) of the PHSA; 42 U.S.C. §282(j)(5)(B).

This certification requirement became law as part of the new clinical trial transparency regime enacted by §801 of the Food and Drug Administration Act Amendments of...
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