The 7-page document provides an update on TransCelerate’s Risk-based Monitoring (RBM) initiative. It includes a list of lessons learned, shares FDA feedback on RBM pilot studies, and provides links to RBM training developed by TransCelerate (TCB) member companies. It also outlines 2014 publishing plans.
We've created this blog to share our perspective on happenings and trends in the pharmaceutical, device, and supplement industry. We welcome your feedback.
Thursday, January 30, 2014
Monday, January 27, 2014
The Plain Writing Act of 2010: Lessons for Industry
FDA and other federal agencies are bound by the Plain Writing Act of 2010 to use “clear government communication that the public can understand and use.” It seems ridiculous that we’d need legislation for such a thing, since “understandable” and “useful” are such obvious and fundamental attributes of communication. There’s even a companion document, the 118-page Federal Plain Language Guidelines (FPLG).
Be us not, in industry, too smug.
Be us not, in industry, too smug.