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US FDA And EMA Officials Work To Boost Interest In Parallel Scientific Advice Program

 
• By Derrick Gingery

Timeline and predictability concerns aren’t supported by recent data, officials argued, but questions may linger about the eligibility of products with device components.

Business handshake and business people on deal concept. vintage tone. - Image
Sponsors complain the PSA process is unpredictable and too long. • Source: Alamy

Officials at the US Food and Drug Administration and European Medicines Agency want to dispel some myths about parallel scientific advice (PSA) to encourage more sponsors to use the program.

The PSA program allows sponsors seeking approval from both regulators to receive scientific opinions from them at the same time,...

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