Category US FDA

Project Orbis, an FDA initiative to facilitate faster access to innovative cancer therapies

Last updated: 18 October 2024 To see updates, click the’+’ sign below: This post is an attempt to provide some basic information on Project Orbis, an FDA initiative to facilitate faster access to innovative cancer therapies. An important limitation in…

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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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