Clinical Trial Disclosure & Data Transparency

Hyatt Regency Bethesda

How the Critical Path Initiative Addresses CDER’s Regulatory Science Needs

By Mark Geanacopoulos, PhD; Ruth Barratt, PhD, DVM; CDER, Office of Translational Sciences

Since 2008, the Critical Path Initiative has supported FDA’s program of intramural research projects in regulatory science, with…

Clinical Data Transparency

By Janet Woodcock, MD, Director, CDER, FDA; Anne M. Rowzee, PhD, Lead Writer/Editor, Division of Online Communications, FDA

Many developments have brought clinical trial data transparency to the forefront of our stakeholders’ minds – from the expanding...

Budget, Funding and HTA Updates from Canada

By Judith Glennie, PharmD; President, J.L. Glennie Consulting, Inc., Canada

Outside of its regulatory responsibilities, the federal government’s role in the Canadian health system tends to be limited...

Advancing the Science of Study Endpoints

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