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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
The Supreme Court on Wednesday, in a closely-watched case, issued a unanimous 9-0 ruling stating that regardless of whether a patent holder is the plaintiff or defendant in a patent infringement case, the burden-of-proof for infringement remains with the patent holder. Read More
Ranbaxy’s regulatory woes deepened Thursday 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
A key panel of the European Parliament on Wednesday advanced draft legislation revising EU clinical trial regulations, setting up a final vote for replacing the current trial directive in April. Read More
A new Tufts University report praises the FDA’s breakthrough therapy program for its potential to advance new drugs and biologics targeting unmet needs. Read More