Regulatory Beat

Sep 15, 2015
BioPharm International
Manufacturers challenge details in new policies designed to promote access to important therapies.
Sep 01, 2015
BioPharm International
Legislation to streamline drug development may get tangled up in user fee negotiations and drug pricing battles.
Aug 01, 2015
BioPharm International
FDA and industry support global framework and collaborations to secure the supply chain.
Jul 01, 2015
BioPharm International
Manufacturers and FDA look for innovative strategies to meet accelerated timeframes.
Jul 01, 2015
BioPharm International
The European Union has a challenging task ahead as it strives to harmonize regulations on advanced therapy medicinal products.
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The draft guidance contains policies for drugs that are processed with additional manufacturing steps such as remixing, dilution, and repackaging.
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