Standards/Regulations

Dec 05, 2017
By BioPharm International Editors
Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.
Nov 27, 2017
Manufacturers and trading partners struggle to meet drug tracking requirements
Nov 16, 2017
By BioPharm International Editors
Commissioner Scott Gottlieb, MD, outlined a plan to support innovation of regenerative medicines while ensuring public safety.
Nov 10, 2017
By BioPharm International Editors
Two of the medicines recommended for approval are orphan drugs.
Nov 07, 2017
By BioPharm International Editors
While most pharma companies are in partial production using generators, few are operating at 100% capacity.
Nov 07, 2017
By BioPharm International Editors
The debate continues over biosimilar naming, interchangeability, and patent protection, as well as lingering concerns in the medical community about the safety of switching patients to new therapies.
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.
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