Mintz attorney Benjamin Zegarelli says FDA needs to develop creative ways to regulate software as a medical device while it waits for Congress to give...
FDA associate commissioner for global policy and strategy Mark Abdoo says the agency is requesting funds to begin expanding its foreign operations.
A petition submitted by a Charles Ludlam calls on FDA to require additional clinical trials to examine the loss of lean muscle mass associated with us...
FDA grants MindMed a breakthrough designation for its MM120 (lysergide d-tartrate) program for treating generalized anxiety disorder.
Pharmaceutical Research and Manufacturers of America says FDA should allow drug companies to seek waivers from the one-page patient medication informa...
FDA accepts for review an Xcovery Holdings NDA for ensartinib, an anaplastic lymphoma kinase (ALK) inhibitor for treating adult patients with metastat...
Federal Register notice: FDA seeks comments on a new proposed information collection entitled Proposed Small Dispensers Assessment Under the Drug Supp...
Par Pharmaceutical recalls one lot of treprostinil injection due to the potential for the presence of silicone particulates in the product solution.
