Generic Industry Wants US FDA To Consider Allowing Foreign Reference Products For ANDAs
If agency adopts policy, it might obviate the need for the CREATES Act. Biosimilars already enjoy a degree flexibility of on the source of reference material that generic sponsors want extended to the less complicated small molecule drugs.
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US FDA will determine on a case-by-case basis whether its inability to inspect a facility because of the pandemic could result in 180-day exclusivity forfeiture for first generic filers.
Meeting management and some application assessment changes also may be necessary as stakeholders prepare for the second biosimilar user fee program reauthorization.
The idea could help quiet growing criticism over system gaming and high drug prices.