FDA warns Akorn about CGMP violations at its Somerset, NJ, drug manufacturing facility, as well as similar violations at other facilities.
FDA releases its latest batch of Warning Letters that includes Akorn, AllerQuest, Clinicon, Izeen Pharma and U.S. Pharmaceuticals.
FDA warns Aurobindo Pharma about CGMP deviations at an API manufacturing facility in India.
Federal Register notice: FDA reopens the comment period for the notices that published in the Federal Register of 4/15 and 4/28 regarding issues relat...
Federal Register notice: FDA corrects a 9/5/2017 notice entitled Providing Regulatory Submissions in Electronic Format Content of the Risk Evaluation...
Federal Register notice: FDA determines that U.S. Pharmaceutical Holdings Claforan (cefotaxime sodium) for injection was not withdrawn from sale for r...
A Science journal exclusive report documents a drop in FDA enforcement activity under the Trump administration.
Two Hyman, Phelps attorneys discuss lessons industry should learn from civil and criminal cases against medical device manufacturer ACell.