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The FDA has agreed to review Purdue Pharma's NDA for its investigational Targiniq ER controlled-release tablets CII for the management of chronic pain. Read More
The European Medicines Agency (EMA) has provided generic drugmakers its first roadmap to meeting standardized EU bioequivalence requirements. Read More
Tamper-evident packaging and registered product trademarks are two features Johnson & Johnson (J&J) employs to minimize a product’s risk of being counterfeited or diverted. Read More
Positive results from the first long-term trial of evolocumab, Amgen’s next-generation heart drug, are heating up the race to develop the emerging class of drugs known as PCSK9 inhibitors. 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
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