Regulatory Beat

Jun 01, 2015
BioPharm International
Regulators and industry seek to streamline and harmonize oversight of postapproval changes.
May 01, 2015
BioPharm International
Drug manufacturers face added pressure and incentives for meeting new FDA compliance policies and priorities.
Apr 01, 2015
BioPharm International
More reliable operations would accelerate product development and prevent drug shortages.
Mar 01, 2015
BioPharm International
Scientists and industry experts seek effective preventive therapies to combat global disease.
Feb 19, 2015
BioPharm International
The draft guidance contains policies for drugs that are processed with additional manufacturing steps such as remixing, dilution, and repackaging.
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.
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