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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drugs containing acetaminophen should warn patients about the risk of serious skin reactions, according to an FDA draft guidance.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
Manufacturers are urging the FDA to ax three proposed quality metrics related to annual product reviews that would measure a facility’s quality culture, claiming they are too burdensome, unnecessary and confusing. Read More