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- EMA publishes guidance on voluntary electronic product information submissions for EU MAAsThe European Medicines Agency released new guidance detailing how companies should provide electronic product information (ePI) when filing marketing authorization applications under the EU's centr…
- FDA makes CBER and CDER leaders permanent amid pending commissioner confirmationThe FDA announced that the heads of its two major centers, CBER and CDER, have been given permanent appointments. The move provides stability for the centers that oversee biologics and drugs, resp…