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US FDA Floats Communications Upgrade For ANDAs With Missed Goals

 
• By Derrick Gingery

Sponsors of generic drug applications that miss a goal date, but do not receive an action because of complex scientific or legal questions, would get a notice outlining the lingering issue as part of a new pilot program that might become permanent in the next review cycle.

The OGD communications pilot could launch in November. (Shutterstock)

Generic drug sponsors may no longer have to wonder why an ANDA had not received a US Food and Drug Administration action if it continues to linger more than two months after its goal date.

Key Takeaways
  • The FDA will provide status updates to generic sponsors if complex issues delay an action as part of a new pilot program.

A pilot program potentially launching in November will improve communications in those situations. When a complex regulatory issue forces the FDA to miss an ANDA goal date and not take...

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