Regulatory Beat

Dec 01, 2014
BioPharm International
Operational changes at FDA and CDER aim to improve global market monitoring.
Nov 01, 2014
BioPharm International
Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.
Oct 01, 2014
BioPharm International
Demand for new therapies and vaccines spotlights production challenges.
Sep 01, 2014
BioPharm International
FDA demands accurate manufacturing and test information to ensure product quality.
Sep 01, 2014
BioPharm International
As the pharmacovigilance infrastructure becomes more entrenched in Europe, drug manufacturers are beginning to feel the burden of its high cost.
Aug 01, 2014
BioPharm International
FDA seeks high quality applications and products to facilitate approvals and reduce safety and supply problems.
Jul 01, 2014
BioPharm International
Stakeholders face challenges and benefits from a more secure pharmaceutical supply chain.
May 02, 2014
The rising incidence of medicine defects and shortages stemming from sub-standard manufacturing is forcing Europe to give higher prominence to more effective inspections procedures.
May 01, 2014
BioPharm International
New formulations and expanded vaccine production are encouraged.
Apr 01, 2014
BioPharm International
As Europe strives to firmly incorporate quality-by-design principles, there are several key issues that still need to be addressed.
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