OR WAIT null SECS
March 02, 2017
Policies limiting imports and immigration generate uncertainty for US and foreign firms
Efforts to harmonize the fragmented regulatory framework for pharmaceuticals in the European Union continue to be a challenge.
February 02, 2017
Early-access schemes aim to make medicines available to patients faster but the regulatory framework remains unclear especially for biologics that involve complex manufacturing.
User fee reauthorization is crucial to implementing the Cures Act and refining the approval process.
January 02, 2017
FDA plans to advance initiatives for ensuring reliable production of drugs and biologics in 2017.
January 01, 2017
How involved should HTA bodies be in assessing cost effectiveness and reimbursements?
December 02, 2016
Better co-ordination within and between regions is needed to improve the global regulation of medicines, according to the European Medicines Agency.
Republican control of Washington promises overhaul of healthcare and medical product regulation.
November 02, 2016
Reliable, high-quality products require innovative analytics and production.
Robust data integrity begins with both management and employees embracing a quality culture and successful implementation of data governance measures.