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September 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.
September 11, 2018
The agency approved Teva Pharmaceutical’s Cassipa (buprenorphine and naloxone) sublingual film for the maintenance treatment of opioid dependence.
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.
September 10, 2018
FDA, innovator companies, and biosimilar developers maneuver over exclusivity, naming, interchangeability, and more.
September 04, 2018
As it investigates the root cause of an impurity discovered in valsartan, FDA extends its studies to APIs with similar synthesis processes.
September 02, 2018
The European Commission’s proposed amendment on SPC waivers has sparked opposing views from drug originators and producers of generic drugs and biosimilars.
August 30, 2018
The European Commission (EC) has approved GlaxoSmithKline’s (GSK) Nucala (mepolizumab) as an add-on treatment for severe refractory eosinophilic asthma in pediatric patients six to 17 years old.
August 29, 2018
PDA Technical Report 80 (TR 80): Data Integrity in Laboratory Systems is the first in a series of three technical reports PDA will publish on data integrity.
August 28, 2018
The European Commission (EC) has approved Novartis’ chimeric antigen receptor T cell (CAR-T) cell therapy Kymriah for the treatment of B-cell acute lymphoblastic leukemia and relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.
A wave of potentially impure drugs and APIs from China, India, and other foreign firms has prompted recalls and FDA warning letters.