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A new Citizen Petition contends the FDA should revoke Ranbaxy’s first-to-file market exclusivity status on several lucrative generic drugs due to a clear history of manufacturing problems and intentional false statements made by the Indian generics company. 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
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
Indian generics maker Sun Pharmaceutical said that it will close its Detroit, Mich., plant this summer as part of its consolidation of U.S. manufacturing operations. Read More
Mylan and Actavis are challenging the FDA’s April 24 decision to grant 180-day marketing exclusivity to Teva for a generic version of the blockbuster arthritis drug Celebrex. Read More
A federal appeals court has ruled that generic manufacturers of Merck’s osteoporosis drug Fosamax cannot be held liable for “design defect” claims against the product. Read More
A judge in London’s high court has ruled that local healthcare provider organizations known as Clinical Commissioning Groups (CCGs) cannot choose to ignore UK health guidance simply because they disagree with it. Read More
The FDA is seeking industry feedback on a proposed study to better understand direct-to-consumer advertisements that compare drug pricing, and how that information affects a consumer’s perception of a drug’s overall safety and efficacy versus the comparator product. Read More