Execs On The Move, July-August 2014
Executive Summary
Recent executive-level company changes and promotions in the biopharma, medical device, and diagnostics industries.
You may also be interested in...
Korea’s First Home-Grown COVID-19 Vaccine To Speed Hub Ambitions
Only one last step remains before the approval of South Korea’s first home-grown COVID-19 vaccine as SK Bioscience’s SKYCovione (GBP510) receives positive assessments from review committees. Any nod, which could happen this week, would mark a milestone for the country's ambitions of becoming a global vaccine hub.
Expanding US OTC Switches Turns On Flexibility In FDA Drug Approval Process And For Consumers
“Nonprescription Drug Product with an Additional Condition” for OTC use proposed rule would add to drug firms’ workloads for some OTC switches. Along with NDAs, sponsors would need to show a DFl isn’t sufficient to ensure a consumer can appropriately self-select and use a drug OTC and how an “additional condition” system would work.
After 10 Years, US FDA ‘Additional Conditions’ Proposed Rule Offers ‘Novel Switch’ Pathway
Publication of "ACNU" proposed rule wasn’t reached in straight line and featured coining another term with more of a regulatory sound, “NSURE,” and detours on explaining where the agency wouldn’t steer OTC drug manufacturing and marketing.