Drug Lawyers: FDA’s Complete Response Letters Are Anything But

Drug industry lawyers are calling for FDA to give more specific feedback during new product reviews to drug applicants, saying the agency’s current process leaves out crucial details and makes the process more frustrating and contentious than necessary. In a Thursday (Oct. 25) post on FDA Law Blog , Deborah Livornese, James Ellison and Josephine Torrente, who are, respectively, of counsel and directors at Hyman, Phelps & McNamara, write that both industry and FDA would benefit if the agency released...