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The FDA plans to ease requirements for trials of drugs aimed at treating hospital-acquired or ventilator-associated bacterial pneumonia, including allowing sponsors to enroll some subjects in trials before a confirmed diagnosis and easing restrictions on prior antibiotic use — both contentious limitations imposed in current guidance. Read More
The FDA says it will reach out to holders of roughly 375 prescription drug applications filed before June 2001 and ask them to voluntarily adopt the user-friendly labeling format created under the “Physician Labeling Rule.” Read More
The FDA slammed biologic manufacturer Greer Laboratories in a warning letter for extensive quality problems, including the presence of pests in its manufacturing plant, and making unapproved allergenic extracts. Read More
Brand drugmakers have been enthusiastic supporters of the FDA’s plans to offer five years of market exclusivity for more fixed-dose combination products — but they want the agency to broaden its new policy so it will cover products already under review. Read More
The U.K.’s Medicines and Healthcare products Regulatory Agency and the British Generic Manufacturers Association next month will launch a forum to promote manufacturing quality. Read More
Indian drugmaker Wockhardt has received the regulatory green light to resume manufacturing and selling its combination drug to treat pain, the company said April 28. Read More
European regulators are urging manufacturers of biosimilar insulin-containing products to demonstrate similar pharmacokinetic and pharmacodynamic (PD) profiles as the gold standard in proving efficacy similarity to the reference products. Read More
A new bipartisan caucus on Capitol Hill plans to educate lawmakers and staff on the role that affordable pharmaceuticals and biologics can play in improving health outcomes and lowering healthcare costs. Read More
A federal judge has ruled against generic makers Par Pharmaceuticals and Impax Labs in their patent challenges to Avanir Pharmaceuticals’ pseudobulbar affect drug Nuedexta. Read More
Indian Cabinet Secretary Ajit Seth and other top Indian officials met last month to devise a framework for discussions about intellectual property rights with U.S. drugmakers, a number of whom have lost patent protection in India in recent months. Read More