Standards & Regulation

Dec 24, 2014
Teva Pharmaceuticals announced that FDA approved Granix injection for self-administration in patients.
Dec 22, 2014
By PharmTech Editors
FDA announced that it approved a new antibacterial drug, Zerbaxa, for the treatment of complicated intra-abdominal infections and complicated urinary tract infections.
Dec 22, 2014
FDA set several milestones in approving more new, important drugs and biologics in 2014. Breakthrough drug designations went through through the roof, speeding more new therapies for cancer and critical conditions to patients.
Dec 19, 2014
The first stem-cell medication approved in the EU promotes regeneration and healing to the outer layer of the cornea.
Dec 19, 2014
By PharmTech Editors
The Committee for Medicinal Products for Human Use recommended seven new medicines at a December 2014 meeting, including weight management and Parkinson’s disease treatments.
Dec 19, 2014
FDA has scheduled a public meeting in early January to assess and weigh data on the first United States application for a biosimilar therapy.
Dec 19, 2014
The European Medicine’s Agency announced recommendations regarding the use of antibiotics in animals to limit resistance in humans.
Dec 18, 2014
By PharmTech Editors
ICH elemental impurities guideline sets a global policy for limiting metal impurities in drug products and ingredients.
Dec 17, 2014
By PharmTech Editors
FDA drug approvals are up in 2014 with biologics drugs representing more than 25% of FDA approvals to date.
Dec 17, 2014
By PharmTech Editors
The agency publishes two guidance documents on providing regulatory submissions in electronic format.