Regulatory Beat

Feb 01, 2017
BioPharm International
User fee reauthorization is crucial to implementing the Cures Act and refining the approval process.
Jan 01, 2017
BioPharm International
FDA plans to advance initiatives for ensuring reliable production of drugs and biologics in 2017.
Jan 01, 2017
BioPharm International
How involved should HTA bodies be in assessing cost effectiveness and reimbursements?
Dec 01, 2016
BioPharm International
Republican control of Washington promises overhaul of healthcare and medical product regulation.
Oct 01, 2016
BioPharm International
Efforts to accelerate drug development will alter fee structure and require ready production sites.
Sep 01, 2016
BioPharm International
Manufacturers and regulatory authorities seek coordinated lifecycle management policies.
Aug 01, 2016
BioPharm International
Regulators and manufacturers address economic and ethical issues for scarce medicines.
Jul 01, 2016
BioPharm International
Agency guidance and industry standards aim to reduce lapses and improve quality operations.
Jun 01, 2016
BioPharm International
More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars.
Jun 01, 2016
BioPharm International
FDA and bio/pharma companies get serious about continuous manufacturing to ensure product quality.
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