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Shortly after Duchesnay received FDA approval for its morning sickness drug Diclegis, the agency says the Canadian drugmaker sent a letter to customers touting the drug’s benefits but none of its risks. Read More
The FDA is proposing to give generic drugmakers the power to revise product labeling in response to safety issues prior to agency approval — a power that brand drugmakers already have. Read More
Despite not agreeing on primary endpoints with the FDA before beginning clinical trials for a new sleep disorder drug, Vanda was able to get an almost unanimous recommendation from an advisory committee earlier this month. Read More
The FDA plans to launch a study examining how consumers view risk information in direct-to-consumer (DTC) prescription drug advertisements, the latest study delving into how drugmakers craft ads. Read More
With EU lawmakers and the European Council expected to reach a compromise on the Clinical Trial Regulation before Christmas, pharma, researchers and patient groups are pleading with them to ensure the timelines for submissions are predictable and no longer than those already established in the current directive. Read More
The FDA Tuesday hit Wockhardt with a second “import alert,” banning drug products from its Chikalthana plant in western India — the latest in a spate of regulatory actions taken against the struggling drugmaker. Read More
The Generic Drug User Fee Amendments of 2012 do not allow for a waiver, reduction nor postponement of finished dosage form (FDF) facility fees for small and/or foreign businesses, the FDA says in a letter denying Square Pharmaceuticals’ citizen petition requesting a waiver and change to GDUFA’s statutory language. Read More
Congressional negotiators are working to hammer out a new federal budget proposal for fiscal 2014 and fiscal 2015, and a group of lawmakers hope to use the budget deal to shield FDA user fee revenue from any across-the-board sequestration cuts. Read More
President Barack Obama Wednesday signed into law a bill that establishes both a nationwide track-and-trace requirement for prescription drugs and a system of voluntary FDA oversight of compounding pharmacies. Read More
The FDA has handed Forest Laboratories and Gedeon Richter a complete response letter asking for more data on cariprazine, the companies’ drug candidate to treat schizophrenia and manic or mixed episodes of bipolar I disorder in adults. Read More
Shortly after Duchesnay received FDA approval for its morning sickness drug Diclegis, the agency says the Canadian drugmaker sent a letter to customers touting the drug’s benefits but none of its risks. Read More
President Barack Obama Nov. 27 signed into law a bill that establishes both a nationwide track-and-trace requirement for prescription drugs and a system of voluntary FDA oversight of compounding pharmacies. Read More