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Sharp price spikes for some orphan generics may be getting all of the attention today, but they have little real impact on overall prescription drug prices. Read More
The FDA is not in the business of regulating drug prices, CDER Director Janet Woodcock told a Senate committee Jan. 28, pushing back against criticism that the FDA should tackle rising drug prices. Read More
Dr. Reddy’s Laboratories has adopted a unique strategy to bypass legal issues surrounding its generic version of Nexium: changing the color of its capsules. Read More
Physician groups frustrated with federal plans to pair different biosimilar drugs together for billing and reimbursement purposes are turning to Congress for help. Read More
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
A law firm that represents drugmakers is urging the FDA to rethink its stance on granting meetings with senior agency officials, saying the existing policy can imperil drug research. Read More
The House Energy & Commerce Committee is calling on the GAO to evaluate whether the FDA’s regulatory pathway for generic versions of complex drugs is sufficient. 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
The director of FDA’s CDER has laid out new priorities for the center to focus on in 2016, with negotiations for GDUFA and improvements at the Office of Generic Drugs among the center’s “front burner” priorities. 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