On September 29, 2010, the Food and Drug Administration (FDA) issued a final rule to clarify the requirements governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND). The rule also imposes bioavailability (BA) and bioequivalence (BE) studies to safety reporting requirements (the Final Rule). 75 Fed. Reg. 59935 (September 29, 2010). The Final Rule, which becomes effective March 28, 2011, was concurrently published with a draft guidance for industry and investigators, entitled Safety Reporting Requirements for INDs and BA/BE Studies (hereinafter referred to as Guidance Document).
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