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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.

  • AAM will look into potential reasons for the lack of interest

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 regulators simultaneously

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