The demise of the Global Harmonization Task Force as a regulator-plus-industry forum for harmonization – or “convergence,” as the cautiously optimistic like to say – was met with little more than silence from the trade associations, but one can be…
Author Archives: Mark McCarty
Once again, the FDA budget dynamic
April 23, 2012 – 7:35 AM
No doubt some are tired of hearing me go on about the FDA budget, but industry thinks the agency is under-funded, too. Most who are part of this discussion believe FDA would be more functional with appropriate appropriations, but they…
Myriad, Prometheus and life science patents: The End of Days?
April 9, 2012 – 7:53 AM
The Supreme Court decision in Mayo v. Prometheus and the Court’s remand of Myriad have provoked a lot of angst on the part of those in the life sciences. Still, the degree to which these cases might prove cataclysmic is…
