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TWi Pharmaceuticals’ bid to market a generic version of Par Pharmaceutical’s AIDS drug Megace ES was dealt a major blow last week after a federal appeals court overturned a lower court’s ruling that had cleared the way for the product. Read More
A compounding pharmacy pled guilty last week to manufacturing contaminated products that caused skin infections, the first compounder to be convicted of criminal charges for poor quality since the FDA gained new authority in 2013. Read More
The European Union has banned imports of Ranbaxy’s injectable antibiotic cephalosporin following an inspection by German regulators who found the company’s Dewas, India, facility was not in compliance with good manufacturing practices. Read More
Manufacturers of prescription and over-the-counter drugs containing acetaminophen should warn patients about the risk of serious skin reactions, according to an FDA draft guidance. Read More
Drugmakers may soon have to report to the FDA how they decide when to launch a CAPA investigation, if they have a performance index for their product’s critical quality attributes and the seniority level of the employee who signs off on the annual product review. Read More
King Pharmaceuticals received a Form 483 after agency investigators discovered problems with damaged equipment and cleanroom suits filled with holes. Read More
The FDA is considering a new inspection scoring system that would for the first time recognize drugmakers that go beyond normal compliance with good manufacturing practices. Read More
The FDA wants to make it easier for generics firms to acquire samples from brandmakers who claim drug safety protocols prevent them from selling the products for bioequivalence testing. Read More