Category Scientific Advice

EMA and FDA launch pilot program for parallel scientific advice (PSA) for hybrid products and complex generic products

Last updated: 7 February 2024 See updates at the end of the post. The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have established a pilot program to provide parallel scientific advice (PSA) to applicants of…

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EU launches Phase 2 of the Simultaneous National Scientific Advice (SNSA) pilot

The EU Innovation Network (EU IN) has launched Phase 2 of the simultaneous national scientific advice (SNSA) pilot. The EU IN started Phase 1 of the pilot for Simultaneous National Scientific Advice (SNSA) from the National Competent Authorities (NCAs) in February 2020. The pilot was extended to the end…

Read MoreEU launches Phase 2 of the Simultaneous National Scientific Advice (SNSA) pilot