Standards/Regulations

Nov 06, 2017
By BioPharm International Editors
The voluntary recall is due to blister packages containing the incorrect product.
Nov 03, 2017
By BioPharm International Editors
FDA sent warning letters to four companies illegally selling products online that claim to prevent, diagnose, treat, or cure cancer without evidence to support these statements.
Nov 03, 2017
By BioPharm International Editors
The agency gave Breakthrough Therapy Designation to GSK’s GSK2857916 monotherapy for the treatment of patients with multiple myeloma who have failed at least three prior lines of therapy.
Nov 01, 2017
BioPharm International
The level of formality in change control may be holding back your SOP progress, according to Siegfried Schmitt, principal consultant at PAREXEL.
Nov 01, 2017
BioPharm International
FDA seeks to focus on problematic facilities and inform firms quickly about site problems.
Nov 01, 2017
BioPharm International
Siegfried Schmitt, PhD, principal consultant, PAREXEL, discusses how to prepare for an inspection by a foreign regulatory agency.
Nov 01, 2017
BioPharm International
Reliable, high-quality products require innovative analytics and production.
Oct 31, 2017
By BioPharm International Editors
A mutual recognition agreement to accept inspection data from eight EU regulatory authorities may reduce inspection burdens at global drug facilities.
Oct 25, 2017
By BioPharm International Editors
FDA sent a warning letter to Ridge Properties, LLC, after inspectors found a variety of current good manufacturing practice violations at the company’s Salem, OR facility.
Oct 11, 2017
By BioPharm International Editors
FDA published guidance on the format and content of REMS documents.
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