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Failing to communicate with a sponsor in a timely manner or collect data from clinical sites may be signs that a CRO isn’t doing its job — and a sign that it’s time for the sponsor to find a new partner, experts say. Read More
The UK’s Medicines and Healthcare products Regulatory Agency is now accepting applications for its Early Access to Medicines Scheme, which allows drugs for life-threatening diseases to be approved on an interim basis and made available to patients sooner. Read More
Australian drug regulators have adopted their European counterparts’ definition of “commercially confidential information” — a move that is raising concerns among some drugmakers who contend that not enough consultation takes place with manufacturers to ascertain what constitutes CCI prior to its disclosure. Read More
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