US FDA Generics Applications Will Cost Less In FY 2020
Increases in the number of expected ANDA submissions, facilities and entities holding approved applications means lower user fees in most GDUFA II categories starting 1 October; program fee will see the largest percentage drop, amounting to savings of $200,000 for large companies.
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FDA's predictions have been pretty consistent; actual submissions haven't been.
Coronavirus Notebook: Fauci Calls For Restraint In Disclosing Early Data; Bipartisan Lawmakers Want Warp Speed Audit
Dispatches from a world turned upside down also include the conditional approval of remdesivir in South Korea.
US FDA’s ‘may be effective’ standard for granting an emergency use authorization is expected to be comparable to the substantial evidence of effectiveness needed to support full licensure of a COVID-19 vaccine, although EUA allows for a more rapid review, agency officials say.