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The UK’s Medicines and Healthcare products Regulatory Agency (MRHA) is reminding drugmakers they must report all defects in medicinal products that could lead to a recall immediately upon discovery and provide regular updates on internal investigations into the defects. Read More
The FDA wants IND sponsors to stop the practice of routinely using age limits as exclusion criteria for clinical trials and increase the number of patients with multiple chronic conditions included in drug studies. Read More
The FDA on Feb. 1 will begin sending status updates to all drugmakers with pending ANDAs to allow them to better estimate when their products can launch. Read More
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