FDA Updates Guidance On ANDAs During COVID
Question And Answer Document Revised To Provide Extra Clarity And Detail
Updated Q&A guidance on developing generics for submission via the abbreviated new drug application pathway during the COVID-19 pandemic has been published by the FDA.
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Guidance published by the US FDA in the form of a question-and-answer document addresses questions from ANDA applicants about generic drug development during the COVID-19 pandemic.
Guidance on protecting participants in bioequivalence studies during the COVID-19 pandemic has been published by the FDA.
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