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Parallel Scientific Advice: Is The EMA User Fee Impacting Interest?

 
• By Derrick Gingery

EMA charges participants to receive scientific advice through the fledgling program, unlike the US FDA, which may not fit the budgets of some complex generic sponsors. At the same time, sponsors also may simply not be aware the program exists yet.

US-EU cooperation
A lack of awareness of the PSA program for complex generics may be contributing to the lack of interest in it. • Source: Shutterstock

As US and European regulators look to boost interest and participation in the parallel scientific advice program for complex generics, a fee that sponsors don't want to pay could be hindering participation just as some may not be aware of the program at all.

The program allows sponsors to meet with US Food and Drug Administration and European Medicines Agency officials to gain alignment...

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