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The European Medicines Agency is establishing a task force to implement common standards for identifying medicines across EU member states, and will require industry and regulators to comply with them beginning in July 2016. Read More
Drugmakers should review their inspection standard operating procedures for producing off-site records and allowing FDA investigators to take photos or conduct interviews of employees, following new agency guidance on the topics. Read More
Five Industry groups are jointly launching a new data center, the European Medicines Verification Organization, to help eliminate counterfeit drugs from the drug supply chain. Read More
The Delhi high court late last month set aside a government order rejecting Gilead’s patent for hepatitis C treatment Sovaldi, saying the Office of Patents Designs and Trademark had made procedural errors in issuing its decision. Read More
Interested parties will soon get another crack at submitting comments on the FDA’s highly controversial proposed rule that would give generics makers authority to update their labels independently — authority only brandmakers currently have. Read More
The FDA is giving industry until March 9 to again weigh in on the controversy surrounding generic first-filer exclusivity determinations and other GDUFA-related issues first raised at a September public hearing. Read More
Long-awaited guidance on designating a biosimilar as interchangeable with the reference product may soon be in the offing, based on an FDA request for comments on a proposed collection of information. Read More
The FDA has again found Upsher-Smith Laboratories’ testosterone gel Vogelxo therapeutically equivalent to Auxilium’s Testim — knocking down Auxilium’s citizen petition demanding higher hurdles for 505(b)(2) NDAs aimed at its therapy. Read More
After serving as FDA commissioner for six years, Margaret Hamburg has resigned, ending a tenure during which the agency boosted its focus on drugs for unmet needs, strengthened policing of compounding pharmacies and increased drug approvals. Read More
A proposal to lift restrictions on how drugmakers can promote products on social media and another that would grant up to 15 years of generics-free exclusivity to drugs approved to treat an unmet medical need are emerging as controversial issues in a proposal to overhaul the FDA’s drug approval processes. Read More