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Drugmakers will be able to make major changes to their products faster under a new European Medicines Agency policy of scheduling new variations reviews weekly rather than monthly. Read More
Three European industry groups are asking the European Commission to block an Italian law that encourages off-label drug use, saying it is driven entirely by economics at the expense of patient health. Read More
The agency is sponsoring research into BE testing for long-acting periodontal drugs and developing methods for assessing generic injectables. Read More
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