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# FDA Wants More PSA Applicants
- URL: https://www.fdaweb.com/fda-wants-more-psa-applicants/
- Published: 2023-07-12T12:00:00.000Z
- Updated: 2026-09-14T18:43:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154864

FDA says it wants more applicants to participate in its Parallel Scientific Advice (PSA) pilot program for complex generic/hybrid drug products. In an agency [podcast](https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/audio-transcript-insights-about-fdaema-parallel-scientific-advice-program-complex-generichybrid-drug?ref=fdaweb.com), CDER Office of Generic Drugs associate director of stakeholder and global engagement **Sarah Ibrahim** says PSA allows applicants to engage in concurrent scientific conversation with both FDA and the European Medicines Agency (EMA) on key issues during the development phase of what FDA calls complex drug products and the EMA calls hybrid products.

“Successful collaboration between FDA and EMA via the PSA program increases dialog between the two agencies and optimizes the applicant’s global product development program by enabling them to discuss specific questions regarding complex generic products and hybrid products,” Ibrahim says. “It further provides applicants with a deeper understanding of the basis for regulatory decisions from both agencies, helping applicants avoid redundant replications of work and unnecessary testing replication or unnecessary diverse testing methodologies. And this in turn can shorten the time to approval.”

Ibrahim reports it has been challenging to get volunteer applicants to participate in this new program. “We evaluated the preliminary assessment of the PSA program to gain insight on how to advance participation, and want to assure applicants that the program has already begun implementation of those recommendations,” she says…. “For each approved PSA request, the agencies will hold one trilateral meeting with the applicant focused on the specific development issues raised…. Meeting requests will be received until FDA and EMA determine the number of completed PSA meetings is sufficient to assess the pilot program.”