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The FDA has denied Public Citizen’s petition to withdraw prescription weight loss drug Xenical and its OTC equivalent Alli from the market, disagreeing with the government watchdog’s concerns that the products cause severe liver damage and offer few benefits. Read More
The FDA is bringing the citizen petition process into the 21st century by allowing for electronic submissions, the agency says in a Federal Register notice published today. Read More
Pfizer will allow Teva to launch a generic of Viagra in the U.S. in 2017 — more than two years before the final patent on the drug expires — under a deal that settles a long-running patent flap. Read More
PhRMA is pushing back against the centerpiece of the FDA’s draft guidance on antibacterial drug development, saying superiority trials for antibacterials that treat drug-resistant infections are “neither routinely possible nor consistently ethical.” Read More
The European Medicines Agency (EMA) has indefinitely postponed a controversial plan to begin releasing to the public detailed information from clinical study reports contained in new drug applications, the central element to its clinical trial transparency initiative. Read More
A citizen watchdog group is again raising concerns about conflicts of interest on FDA advisory committees, charging that the agency should not have allowed a panel member to vote on a drug that a family member was taking. Read More
A new House bill aims to build on the success of the Generating Antibiotics Incentives Now (GAIN) Act by allowing drugmakers to submit less data for antibiotics and antifungals that affect limited patient populations. Read More
Generics makers should design tablets and capsules to be similar in size and shape to their reference listed drug (RLD) when they seek ANDA approval, the FDA says. Read More
Lawmakers want the FDA to explain how hackers broke in to the CBER online submission system to steal personal user information and what the FDA has done to prevent a recurrence. Read More
HHS has approved the overhaul of the FDA’s Office of Generic Drugs (OGD), allowing the agency to move most of its functions relating to generic drugs under one roof. Read More