Regulatory Beat

Feb 11, 2015
The industry reacts to the departure of Commissioner Margaret Hamburg.
Feb 01, 2015
BioPharm International
EMA is under pressure to exert even tighter standards on biosimilars being marketed in Europe.
Feb 01, 2015
BioPharm International
Manufacturers face new rules for tracing drugs through the supply chain and compounders face stricter standards.
Jan 01, 2015
BioPharm International
Manufacturers are under pressure to develop pipelines, promote quality, and justify pricing.
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.
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