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Taking aim at what they call the “skyrocketing costs of pharmaceuticals,” Democratic members of the House Committee on Oversight & Government Reform are slated to launch the Affordable Drug Pricing Task Force during a press conference today. Read More
The pharmaceutical and biologics industries aren’t hiding their displeasure with a decision from the Centers for Medicare & Medicaid Services to treat all biosimilars based on the originator product as identical for billing and reimbursement purposes. Read More
The European Commission released new rules clarifying the responsibilities of qualified persons overseeing global, multisite manufacturing operations and the data they need to collect. Read More
Drugmakers facing a European GMP inspection should be prepared to provide complete documentation of active ingredients throughout the supply chain, going back to the starting materials that were used in the synthesis of the APIs. Read More
FDA’s Office of Manufacturing Quality will now be involved in evaluating all BLAs and supplements to ensure product quality throughout a product’s lifecycle. Read More
The European Medicines Agency conducted 350 good manufacturing practices inspections in the first half of this year — roughly 50 percent more than in the same period a year ago, a new report shows. Read More
Responding to more than a dozen Form 483 responses from compounders that say they’re not subject to FDA GMP requirements, the agency put compounders on notice outlining enforcement penalties and bulk substance rules that compounders must adhere to. Read More
President Barack Obama Monday signed into law H.R. 1314 that would require generics makers to pay inflation-based rebates if prices rise too quickly, based on the inflation-adjusted baseline average manufacturer price. Read More
The senators are asking the FTC to investigate whether the suppliers are taking advantage of the shortage in ways that run afoul of antitrust laws. Read More
The FDA will not be forced into a shutdown this year after the Senate passed a two-year budget early Friday morning for fiscal years 2016 and 2017. Read More