Regulatory

Jul 12, 2018
By BioPharm International Editors
The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.
Jul 03, 2018
By BioPharm International Editors
The European Medicines Agency recommended Novartis’ Kymriah (tisagenlecleucel) and Kite’s Yescarta (axicabtagene ciloleucel), chimeric antigen receptor (CAR) T-cell therapies, for approval in the European Union.
Jul 02, 2018
Legislators look to widen access to medications for addiction treatment and overdose emergencies.
Jul 02, 2018
The agency is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.
Jul 01, 2018
BioPharm International
Biosimilars and biobetters face developmental challenges to achieving commercialization.
Jul 01, 2018
BioPharm International
BioPharm International asked an FDA spokesperson how the agency plans on handling these issues in the future.
Jul 01, 2018
BioPharm International
FDA seeks more efficient testing to spur development of less costly biotech therapies.
Jun 27, 2018
By BioPharm International Editors
FDA sent a warning letter to Henan Lihua Pharmaceutical Co. Ltd. after inspectors found the company failed to ensure the accuracy of its data.
Jun 14, 2018
By BioPharm International Editors
FDA Commissioner Scott Gottlieb, MD, released a statement on new agency efforts to involve the patient voice in medical product development and FDA regulatory decision-making.
Jun 01, 2018
BioPharm International
FDA and Congress seek to limit the production and distribution of pain medicines.
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