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In anticipation of proposed guidance on biosimilar interchangeability, AbbVie is requesting that the FDA hold a hearing to ensure the agency considers all viewpoints. Read More
Citing significant price increases for certain generic drugs, House Republicans have sent a
letter to Acting FDA Commissioner Stephen Ostroff with concerns about the agency’s process for approving ANDAs. Read More
Biosimilar labeling should piggyback on reference product labeling to bolster consumer confidence in this new class of medications, according to an FDA petition. Read More
Last year was a productive one for the FDA’s CDER, which approved 45 novel drugs — an increase from its 2006 to 2014 average of 28, according to the agency’s 2015 Novel New Drugs Summary released Monday. Read More