Standards & Regulation

May 28, 2015
By Pharmaceutical Technology Editors
New guidance complements ICH guidelines on impurities.
May 27, 2015
Eight physician groups wrote to the commissioner of FDA to stress the importance of transparency in biosimilar labeling to decrease prescribing risks.
May 27, 2015
Widespread use and abuse of opioid painkillers is prompting efforts to develop new drugs and formulations that resist abuse while providing relief to legitimate patients.
May 26, 2015
By Pharmaceutical Technology Editors
Boehringer Ingelheim announces FDA approval of Stiolto Respimat inhaler for the treatment of COPD.
May 22, 2015
By Pharmaceutical Technology Editors
Pharmaceutical Technology spoke with Tim Kearns, pharmaceutical and medical devices manager at Videojet.
May 20, 2015
By Pharmaceutical Technology Editors
The former New England Compounding Center will pay $200 million to victims and creditors for the 2012 outbreak of meningitis that killed 64.
May 15, 2015
By Pharmaceutical Technology Editors
Raplixa fibrin sealant, the first approved spray-dried biologic, is a hemostatic agent that helps control bleeding from small blood vessels during surgery.
May 13, 2015
By Pharmaceutical Technology Editors
Pluristem Therapeutics announces that Japan’s Pharmaceuticals and Medical Devices Agency agreed with its methods for the manufacture of PLX-PAD cells.
May 13, 2015
FDA concludes Orkambi demonstrates a clinical benefit over placebo, but questions the magnitude of the improvement.
May 12, 2015
By Pharmaceutical Technology Editors
The agency publishes draft guidance answering industry questions about the Biologics Price Competition and Innovation Act.