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The FDA will agree to meet to discuss the ANDA deficiencies cited in a complete response letter to a sponsor only if the sponsor lists the questions it wants to raise and the people who will participate in the meeting and includes other items spelled out by the agency in draft guidance, the FDA said. Read More
For fiscal 2017, the FDA approved 763 generic drug applications, beating the previous year’s record of 651 by 17 percent. An additional 174 were granted tentative approval. Read More
The FDA published new product-specific draft guidances for 30 active ingredients — including cancer therapies, asthma treatments, epinephrine auto-injectors and anti-infectives — outlining the agency’s preferred methods for supporting ANDA submissions. Read More
The Federal Circuit eased the ability for patent holders to amend their claims when challenged under inter partes review — a hurdle that pharmaceutical industry trade groups had previously described as unfair, ambiguous and impractical. Read More
The FDA published a draft guidance explaining the new GDUFA fee structure and the types of fees that took effect Oct. 1. The draft also covers how to submit payments to the agency, the consequences for failing to pay, and how to request reconsiderations of user fee assessments. Read More
The FDA published a new manual of policies and procedures for reviewing staff, detailing how the agency will communicate ANDA deficiencies with applicants — meeting one of its first commitments for the next generation of GDUFA. Read More
Two AIDS patient advocacy groups urged New York Attorney General Eric Schneiderman — a frequent foe of anticompetitive behavior by drugmakers — to investigate potential pay-for-delay deals by Gilead. Read More
The PTO’s Patent Trial and Appeals Board invalidated Aventis Pharma’s patent for the chemotherapy drug Jevtana (cabazitaxel), following a challenge from Mylan. Read More
A federal judge in Pennsylvania threw out AbbVie’s patent suits against generic competitors, strengthening the Federal Trade Commission’s pay-for-delay case against the drugmaker. Read More
Facing a drastic loss of revenue and market share to a competing generic drug, Indivior said it will appeal an adverse federal court ruling on its patent for Suboxone (buprenorphine and naloxone), a sublingual film indicated for the maintenance treatment of opioid dependence. Read More
An FDA policy proposal on expedited generic drug approvals runs counter to the goals of the program and breaks faith with the upcoming GDUFA II agreement with the industry, generic drugmakers said. Read More