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December 15, 2019
The process used to monitor and participate in pharmacopoeial changes is described.
Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.
Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.
An effective surveillance program for monitoring the activities of pharmacopoeias around the world requires processes, people, and tools from across a company.
December 12, 2019
Newron Pharmaceuticals has received communications from the United States Food and Drug Administration (FDA) suggesting it discusses its proposed statistical plan in a Type A meeting.
Galderma, a Swiss-based dermatology company that the United States Food and Drug Administration (FDA) has granted breakthrough therapy designation to its investigational therapy, nemolizumab.
December 02, 2019
A NASEM report stresses the importance of information sharing by biopharma companies and cooperation among regulatory authorities.
Regulators are facing huge challenges on how to deal with the digitalization transformation occurring in the healthcare and pharmaceutical sectors.
November 14, 2019
NICE has issued a positive recommendation for GW Pharmaceuticals’ Epidyolex (cannabidiol) oral solution for the treatment of seizures in patients with a rare form of childhood-onset epilepsy.
November 02, 2019
An effective quality control unit is independent from manufacturing and ensures current standards are followed.