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Drugmakers want the FDA to provide more details on how it would show regulatory flexibility to developers of drugs for rare diseases, saying recent draft guidance is unclear about what may or may not be appropriate. Read More
The FDA approved GlaxoSmithKline’s injectable drug Nucala Wednesday for use in patients 12 years and older suffering from severe asthma attacks. It is intended to be used in conjunction with other asthma drugs. Read More
Allegations of price gouging within the pharmaceutical industry reached fever pitch in Washington, D.C., yesterday, with House members calling for hearings, a Senate committee opening an investigation into pricing practices and HHS announcing a hearing on the subject. Read More
Mylan may move forward with its proposed hostile takeover bid of Perrigo, as long as it divests seven generic drugs, the FTC has determined. The move is the final regulatory hurdle for Mylan’s bid and eases the FTC’s concerns that the deal would harm competition. Read More
The HHS Office of Inspector General is planning to examine the FDA’s oversight of postmarketing studies of approved drugs and how well information exchange is occurring in the pharmaceutical supply chain as part of its six priorities for the agency in fiscal year 2016. Read More
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