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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
Generic drugmakers and the biotech industry have drafted a set of rules to govern when and how biosimilars can be substituted for brand-name biologics. Read More
The European Medicines Agency (EMA) on Friday said it will investigate reports that emergency contraceptives such as Teva’s Plan B One-Step lose effectiveness in some women who weigh more than 165 lbs. Read More
Sterile injectables maker Hospira was hit with a new Form 483 containing nearly two dozen observations after FDA investigators followed up an October 2012 inspection that uncovered inadequate sanitization procedures at its Irungattukottai, India, facility. Read More
The FDA’s ban on the sale of prescription acetaminophen/opioid combination drugs that use more than 325 mg of acetaminophen per tablet went into effect Jan. 14, and the agency will soon begin withdrawing approvals for products made by companies defying the ban. Read More
Proposed international guidelines on metal impurities in finished drugs may be impossible to meet because they lack specificity and are impractical for suppliers, drugmakers say. Read More
The Pennsylvania Supreme Court has affirmed that drugmakers can be held liable for negligent drug design, opening up a new avenue for patients seeking financial relief for injury claims in the state. Read More