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GlaxoSmithKline has halted global shipments of two chickenpox vaccines after a manufacturing problem in late November caused some batches to fail to meet release criteria and standards, the British drugmaker said Tuesday. Read More
Ranbaxy’s regulatory woes deepened Jan. 23 as the FDA prohibited the drugmaker’s Toansa, India, plant from manufacturing and distributing active pharmaceutical ingredients (APIs) for U.S. products after a poor inspection. Read More
Japan’s national drug regulator has asked drugmakers to submit information on stability monitoring and water purity, in addition to existing requirements, when they apply for mandatory post-approval GMP inspections. Read More
Pharma companies applying for approval to sell drugs in Canada must submit quality summary documents, certifications of their products’ comparability with monographs of the European Pharmacopoeia and detailed drug master files that comply with the International Conference on Harmonisation’s registration for human use quality standards. Read More
Johnson & Johnson Thursday unveiled a clinical trial data-sharing plan that it hopes will become a model for all industry transparency initiatives: instead of providing direct access to trial data, a third party will serve as gatekeeper and approve access requests for data. Read More
GPhA has jumped into the biosimilars substitution debate, saying it prefers that doctors not be notified when a pharmacist substitutes a biosimilar for a name-brand biologic, and it is supporting legislative language that would implement that approach in states throughout the U.S. Read More
European regulators want drugmakers to develop pharmacovigilance plans that include tracking pharmacogenomic data to assess drug safety risks that may apply only to small patient populations. Read More
Jane Axelrad, CDER’s associate director for policy, spoke with Drug Daily Bulletin to discuss the FDA’s strategy for regulating compounding pharmacies. Read More
The Department of Justice (DOJ) wants to see that when it settles a fraud case with a drugmaker the company does not slip back to its old, bad habits once the prosecutors leave, and it’s increasingly using corporate integrity agreements to make that happen. Read More