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Insurers and hospitals will be allowed to pay drugmakers based on the effectiveness of their products, if a bipartisan Senate bill that amends the Social Security Act is passed. Read More
The European Medicines Agency began a six-month public consultation Thursday for draft principles on a common EU standard for human drug electronic product information. Read More
HHS released a proposed rule on Thursday that would target “backdoor” rebates between drugmakers and pharmacy benefit managers (PBMs), restructuring the rebate system to pass the discounts directly on to consumers. Read More
The contingency legislation is needed in order for the Medicines and Healthcare products Regulatory Agency to take on regulatory processes that are currently undertaken by the European Medicines Agency and other bodies. Read More
Scilex Pharmaceuticals urged the FDA to remove unapproved lidocaine patches from the market and issue guidance on the marketing of such products. Read More
The agency is “taking new steps to help ensure that a product’s labeling provides actionable and complete information about the clinical evidence supporting an accelerated approval,” Commissioner Gottlieb said. Read More