Standards & Regulations

Jul 12, 2018
By BioPharm International Editors
The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.
May 14, 2018
By BioPharm International Editors
FDA sent a warning letter to Goran Pharma Private Limited citing inadequate quality control violations.
May 14, 2018
President Donald Trump announced his strategy for making prescription medicines more affordable and accessible in the United States.
May 01, 2018
BioPharm International
A validation plan developed to support a process unrelated to bio-pharmaceutical manufacture is applied to biopharmaceutical processes and systems.
May 01, 2018
BioPharm International
FDA’s commissioner addresses opioid abuse, drug costs, and manufacturing quality.
May 01, 2018
BioPharm International
Monetary benefits will outweigh the hassle of batch record harmonization, says Siegfried Schmitt, principal consultant at PAREXEL.
Apr 30, 2018
By BioPharm International Editors
The company received a complete response letter from FDA in response to the biologics license application for a proposed trastuzumab biosimilar.
Apr 30, 2018
By BioPharm International Editors
The agency updated its list of recommended influenza virus strains that manufacturers should include in vaccines for the autumn 2018 season.
Apr 30, 2018
By BioPharm International Editors
After a review of public comments, USP will not move forward with nomenclature proposal without further FDA collaboration.
Apr 30, 2018
By BioPharm International Editors
FDA sent a warning letter to Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. for failure to follow current good manufacturing practices.
native1_300x100
lorem ipsum