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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