Regulatory Beat

May 01, 2017
BioPharm International
Recent legislation and PDUFA initiatives aim to streamline oversight and testing requirements.
Apr 01, 2017
BioPharm International
Industry fears limited benefits as FDA readies voluntary data tracking program.
Mar 01, 2017
Manufacturers face uncertainty over imports, regulatory policies, and field inspections.
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.
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