Regulatory

Jan 05, 2017
BioPharm International
The number of novel drugs approved in 2016 by FDA’s CDER department was half the number approved the previous year; many of the complete response letters issued in 2016 were a result of preapproval inspection.
Jan 01, 2017
BioPharm International
FDA plans to advance initiatives for ensuring reliable production of drugs and biologics in 2017.
Aug 01, 2016
BioPharm International
The study demonstrates a systematic approach to stabilize PBS-formulated mAbs against freeze-thaw degradation.
Jul 08, 2016
The agency says that the routine large-scale compounding of drugs that are exact copies of existing medications undermines the the drug approval process.
Jun 28, 2016
By BioPharm International Editors
The monoclonal antibody for the treatment of two forms of multiple sclerosis has a target action date of December 28, 2016.
Jun 01, 2016
BioPharm International
More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars.
May 31, 2016
Samsung Bioepis and partner Biogen announced on May 30 that the European Commission approved Flixabi for the treatment of six inflammatory conditions.
May 26, 2016
By BioPharm International Editors
The agency cited Tai Heng Industry with CGMP deviations, including failure to ensure data integrity.
Mar 09, 2016
The five-year Medicare initiative seeks to change the way in which drugs are reimbursed under Medicare Part B.
Feb 12, 2016
FDA cracks down on makers of products extracted from Cannabis and says the products cannot be considered dietary supplements.
native1_300x100
lorem ipsum