WebJun 30, 2024 · IND Safety Reporting for Marketed Drugs and Active Control; Electronic reporting using ICH E2B standards; INTENDED AUDIENCE. Sponsors of IND or BA/BE … WebJan 16, 2013 · FDA’s December 2012 Guidance on IND and BA/BE Reporting – Part 3. Jan 16, 2013. Bart Cobert. Pharmacovigilance, Drug Safety and Regulatory Affairs Author & Expert. FDA published in December 2012 a final guidance on IND and BA/BE reporting along with a brief Q&A accompanying it.
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WebJun 25, 2024 · The US Food and Drug Administration (FDA) has released a new draft guidance for sponsors on safety reporting requirements and assessments for investigational new drug application (IND) and bioavailability/bioequivalence (BA/BE) studies. http://asbcomment.icai.org/documents/cb17db0eb78992bdcc756b5564fd10dc.pdf got to give it up marvin gaye youtube
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