News-03/29/2017

  UK Triggers Brexit: What’s Next for the UK, MHRA and EMA? UK Prime Minister Teresa May on Wednesday set in motion the UK’s departure from the EU over the next two years, guaranteeing the European Medicines Agency (EMA) will see some significant changes over the next few years. HHS Secretary Working With Trump on …

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News-03/28/2017

  FDA Office of Regulatory Affairs Realignment to Begin in May The US Food and Drug Administration’s (FDA) Office of Regulatory Affairs (ORA), which carries out the agency’s inspection program, will officially begin a major overhaul in the coming weeks, according to FDA’s Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren. Asia Regulatory …

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News-03/27/2017

Pharma Profits Continue to Dwarf R&D Spending as Pressure MountsWith the repeal of Obamacare on life support, the furor over rising prescription drug prices and President Donald Trump’s support for the cause could end up filling the vacant crossroads where bipartisanship meets change. Regulatory Recon: AZ’s Tagrisso First to be Approved Under China’s Priority Review …

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News-03/24/2017

CDRH Seeks Participants for Staff Training ProgramMedical device companies and other stakeholders have until 30 April to apply to be a part of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) Experiential Learning Program (ELP), which is meant to help agency staffers better understand medical devices. Duplicate MAAs: Amgen …

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News-03/23/2017

FDA Issues Guidance on Drugs to Prevent Delayed Graft Function in Kidney Transplant Patients The US Food and Drug Administration (FDA) on Wednesday issued new draft guidance detailing its expectations for drugs intended to treat delayed graft function (DGF) in kidney transplant patients. MHRA Details Common Issues in Clinical Trial Applications The UK’s Medicines and …

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