Regulatory Authority Actions

Sep 20, 2018
By Pharmaceutical Technology Editors
The agency will review Praluent (alirocumab) Injection, a PCSK9 inhibitor, as a possible treatment of cardiovascular events.
Sep 20, 2018
By Pharmaceutical Technology Editors
The agreement now includes 15 European Union (EU) member states.
Sep 17, 2018
By Pharmaceutical Technology Editors
FDA sent a warning letter to Lernapharm (Loris) Inc. detailing the company’s lack of procedures to prevent microbiological contamination.
Sep 14, 2018
By Pharmaceutical Technology Editors
The agency approved AstraZeneca’s Lumoxiti (moxetumomab pasudotox-tdfk) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia.
Sep 14, 2018
By Pharmaceutical Technology Editors
FDA testing has found an additional impurity, N-Nitrosodiethylamine, in the API valsartan.
Sep 12, 2018
FDA is revising its inspection process and seeks harmonization of standards for US and foreign regulatory oversight to ensure the safety of medicines.
Sep 11, 2018
By Pharmaceutical Technology Editors
FDA Commissioner Scott Gottlieb, MD, issued a statement regarding new warning letters FDA issued to Chillin Mix Kratom and Mitra Distributing, companies marketing kratom—a potential source of opioids—with unproven medical claims.
Sep 11, 2018
By Pharmaceutical Technology Editors
The agency approved Teva Pharmaceutical’s Cassipa (buprenorphine and naloxone) sublingual film for the maintenance treatment of opioid dependence.
Sep 10, 2018
FDA, innovator companies, and biosimilar developers maneuver over exclusivity, naming, interchangeability, and more.
Sep 04, 2018
By Pharmaceutical Technology Editors
As it investigates the root cause of an impurity discovered in valsartan, FDA extends its studies to APIs with similar synthesis processes.
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