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Complex Generic Sponsors Not Using US FDA-EMA Parallel Scientific Advice Program

 
• By Derrick Gingery

After nearly two years, the program has received only two requests, driving FDA officials to try to boost interest.

US and EU collaboration
FDA officials believe the FDA-EMA parallel scientific advice program could be beneficial for complex generic sponsors. • Source: Shutterstock

Nearly two years after its creation, the complex generic drug parallel scientific advice pilot program still has not received enough interest to effectively judge its value.

Key Takeaways

  • The FDA wants to drum up more interest in the parallel scientific advice program for complex generics after only two requests have been received.

  • ...

US Food and Drug Administration officials are trying to drum up more interest in the program, which allows complex generics sponsors to receive development advice from US and European Union...

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