FDA Guides On Virtual Inspections During COVID-19
Agency Will Use Video Conferencing Tools To Conduct Remote Evaluations
Details of how the FDA plans to conduct remote evaluations of manufacturing facilities during the COVID-19 pandemic have been set out in guidance published by the US agency.
You may also be interested in...
Biocon is still awaiting a site inspection as pandemic-related delays keep its Viatris-partnered bevacizumab out of the US market, though the Indian company believes it can still make good and garner market share. All eyes are also on traction for its insulin glargine via increased share of formulary contracts.
Former senior FDA official Eva Temkin has criticized the FDA’s silence on the development of biosimilars and interchangeable products in its recent COVID-19 guidance, suggesting that the agency’s stance on 180-day exclusivity for small-molecule generics could be extended to interchangeability exclusivity for biosimilars, while also pointing out that key questions around generic exclusivity are left unanswered
ANDA approval rates have remained steady, while submission rates dropped compared to prior years.