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Since Congress reauthorized the FDA’s generic drug user fee program last Friday, the FDA has published multiple related guidances and other official instructions and directives each day. Read More
A bipartisan bill just introduced in the U.S. House of Representatives seeks to abolish reimbursement restrictions placed on antiamyloid antibodies as a treatment for Alzheimer’s disease. Read More
The drug also received Fast Track status for the treatment of patients with first-line recurrent or metastatic head and neck squamous cell carcinoma. Read More
As part of its commitments under the newly reauthorized Prescription Drug User Fee Act (PDUFA VII), the FDA has launched the Rare Disease Endpoint Advancement (RDEA) pilot that will test a new meeting system to help sponsors of rare disease clinical trials develop efficacy endpoints. Read More
With the Prescription Drug User Fee Act (PDUFA) VII and the other user fee programs now reauthorized, the FDA is announcing work on several new initiatives this week — including the Split Real-Time Application Review (STAR) pilot program. Read More
Currently idle U.S. generic drug manufacturing capacity could keep the nation’s drug supply chain “secure, robust and resilient,” according to researchers at Washington University’s Olin Business School in St. Louis. Read More