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Register notice: FDA determines that U.S. Pharmaceutical Holdings Claforan (cefotaxime sodium) for injection was not withdrawn from sale for r...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.
FDA says ANDAs for products indicated for emergency treatment of known or suspected opioid overdose are eligible for priority review under the HHS pub...
A 7/6 New York Times editorial board opinion piece urges the Trump Administration to curb drug price increases the way Europe does by tying a drugs p...