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The FDA issued a warning letter to Specialty Process Labs for significant deviations from current good manufacturing practices (cGMP) for active pharmaceutical ingredients (API), including failure to validate manufacturing processes and ensure uniform blends. Read More
In a new draft guidance, the FDA presses drug manufacturers to develop risk management plans to further shore up the country’s drug supply chain. Read More
The European Medicines Agency’s (EMA) human medicines committee endorsed nine new drugs during its monthly meeting held from May 16 to 19, including LFB Biotechnologies’ coagulant therapy Cevenfacta (eptacog beta (activated)) for treating congenital hemophilia. Read More
Sens. Chuck Grassley (R-Iowa), Ron Wyden (D-Ore.) and Mike Braun (R-Ind.) are urging the Federal Trade Commission (FTC) to examine how pharmacy benefit managers (PBM) affect the cost of insulin products. Read More
A collection of 24 states is displaying its support to the Department of Health and Human Services (HHS) in its legal fight with several drugmakers over access to drugs discounted under the 340B Drug Discount program. Read More
The Centers for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices voted yesterday to recommend that children between the ages of five and 11 should receive booster doses of the Pfizer-BioNTech COVID-19 vaccine. Read More
FDA Commissioner Robert Califf announced a new role for agency veteran Janet Woodcock in his remarks at a House subcommittee hearing yesterday, where he was slated to speak on the agency’s fiscal 2023 budget request. Read More
A federal court has thrown out a rule that forced pharma companies to include discounts they offer to patients when calculating the so-called best price for Medicaid’s drug rebate program. Read More
The Department of Health and Human Services recommended that the product be kept available for an extra six months for possible use against new variants or subvariants that could become dominant in the U.S. Read More