Standards/Regulations

Jul 10, 2017
By BioPharm International Editors
FDA sent a warning letter to Shandong Analysis and Test Center for CGMP violations including data integrity issues and insufficient testing procedures.
Jul 10, 2017
By BioPharm International Editors
The agency’s Pharmacovigilance Risk Assessment Committee made recommendations on the risk of multiple sclerosis treatments, injectable methylprednisolone medicines, and the use of gadolinium contrast agents.
Jul 01, 2017
BioPharm International
The opening presentation gives the company a chance to put their best foot forward, according to Siegfried Schmitt, principal at PAREXEL.
Jun 29, 2017
By BioPharm International Editors
The agency announced a plan to eliminate its existing orphan designation request backlog.
Jun 28, 2017
By BioPharm International Editors
The directorate highlights its 2016 achievements.
Jun 27, 2017
By BioPharm International Editors
The agency announced it is taking steps to increase competition within the prescription drug market.
Jun 23, 2017
By BioPharm International Editors
The agency recommended approval of treatments for hepatitis C, cancer, multiple sclerosis, and arthritis.
Jun 21, 2017
By BioPharm International Editors
FDA Commissioner Scott Gottlieb announced the agency will hold a public meeting on drug competition as part of its Drug Competition Action Plan.
Jun 16, 2017
By BioPharm International Editors
The agency’s management board discussed plans for the relocation of EMA at its June 2017 meeting.
Jun 15, 2017
Congressional measures lack the support to move forward.
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