The Food and Drug Administration (FDA) announced a new proposal Monday for flexible drug approval pathway treatments addressing ultrarare diseases. The FDA unveiled draft guidance on a proposed ...
San Diego – Officials from the European Medicines Agency (EMA) discussed the different types of expedited approval pathways available to sponsors of innovative drugs and advanced therapy medicinal ...
Late on Wednesday, U.S. Food and Drug Administration (FDA) Commissioner Marty Makary and Center for Biologics Evaluation & Research (CBER) Director Vinay Prasad published an article in the New England ...
In the second part of our FDA: Drug & Device Team’s series on biological products regulation, we discuss the regulatory pathways for biological products under Section 351 of the Public Health Service ...
After teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...
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