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Government auditors Feb. 10 criticized the FDA for its ongoing drug shortages problem, while House lawmakers chastised the agency at a hearing for not taking more action. Read More
PhRMA has placed itself in the middle of a mounting battle over biosimilar naming, calling on the FDA to deny GPhA’s petition for same-name biosimilars and arguing that distinguishable, yet related names are “essential” for adverse event reporting. Read More
The FDA Feb. 1 began sending status updates to all drugmakers with pending ANDAs to allow them to better estimate when their products can launch. Read More
The FTC last week said regulations and legislation governing the naming and dispensation of biosimilars should match those already in place for generic drugs to avoid chilling competition among drugmakers. Read More
Just when things were starting to turn around for Teva, the Israeli drugmaker said Monday it was under federal investigation for potential marketing violations of its drugs Copaxone and Azilect. Read More
Vaccine trial sponsors should report study-related fatalities within seven days of an event and submit follow-up reports by eight days later, a recent China Food and Drug Administration guideline says. Read More
The FDA’s Center for Devices and Radiological Health is working on ways to permit sponsors to use more adult clinical trial data in proving the safety and effectiveness of pediatric medical devices. Read More
A new data standard being proposed by the Clinical Data Interchange Standard Consortium could give sponsors and FDA reviewers greater flexibility to analyze data, if adopted by the agency for drug review applications. Read More
Johnson & Johnson unveiled a first-of-kind clinical trial data-sharing plan that it hopes will become a model for industry transparency initiatives: rather than provide direct access to trial data, sponsors could contract with third parties to serve as gatekeeper and approve data access requests. Read More
While EU regulators push ahead with a trial transparency initiative, the Institute of Medicine has stepped into the debate, seeking feedback on a wide range of proposals to encourage clinical data sharing in the U.S. Read More
The FDA’s breakthrough therapy program is proving its potential to advance new drugs and biologics targeting unmet needs, a new Tufts University report says. But industry interest in the year-old program may wane if the approval times for breakthrough drugs don’t improve. Read More