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Combining the drug portfolios of the merging companies “may give them increased negotiating leverage to force buyers to provide them with more favorable terms across multiple product categories,” the senators said. Read More
The agency will grant a meeting if it concerns a product for which there is no product-specific guidance or an “alternative equivalence evaluation.” Read More
HHS has formally appealed a July ruling by a federal court in Washington, D.C., which blocked the department from requiring drug companies to disclose the prices of drug prices in their direct-to-consumer TV ads. Read More
The FDA is delaying enforcement action for one year against wholesale distributors who fail to comply with certain sections of the Drug Supply Chain Security Act (DSCSA), the agency said in a new guidance released on Tuesday. Read More
The agency is providing a two-year transition period for sponsors to make changes to their manufacturing processes and to implement adequate testing methods. Read More