FDA News

FDA’s CDER Updates the Purple Book

On Tuesday, February 21st, the FDA’s Center for Drug Evaluation and Research (CDER) announced the availability of an updated version of the Purple Book. What is the Purple Book? “The ‘Purple Book’ lists biological products, including any biosimilar and interchangeable... Read More

FDA Releases CDER’s 2017 Guidance Agenda

Last month, FDA’s Center for Drug Evaluation and Research (CDER) released its annual guidance agenda, announcing the new and revised draft guidances that the Center plans to publish during the 2017 calendar year.  CDER’s agenda is organized by category and... Read More
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