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21 February 2020
To provide researchers with more accurate and accessible data about historic drug approvals, the US Food and Drug Administration (FDA) on Friday released a dataset containing information about all new drugs and biologics approved by the Center for...

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21 February 2020
The US Food and Drug Administration (FDA) on Friday finalized the seventh revision to its guidance on making regulatory submissions in electronic common technical document (eCTD) format to specify cases where an exemption or waiver from eCTD requi...
20 February 2020
The US Food and Drug Administration (FDA) on Thursday published a table identifying more than 50 gene-drug interactions that the agency says are supported by scientific evidence and announced it is considering new approaches to evaluating pharmaco...
20 February 2020
A month before the long-anticipated transition of applications for certain biological products, including insulin and human growth hormone, to be deemed to be licensed as biologics, the US Food and Drug Administration (FDA) on Thursday issued a fi...
20 February 2020
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
20 February 2020
With full application of the EU Medical Device Regulation (EU MDR) just around the corner on 26 May 2020, it’s fair to say many device manufacturers and regulatory professionals are on edge. And although we are coming to the end of the three-year ...
19 February 2020
Following a successful pilot that wrapped up in August, Health Canada says it will immediately begin accepting certain clinical trial submissions in electronic common technical document (eCTD) format.