In Case You Missed It: Top 10 "Gray Sheet" Stories In November
This article was originally published in The Gray Sheet
Executive Summary
Our most popular stories last month included an exclusive item on FDA's next steps for its device Case-for-Quality program; a graphical analysis of the agency's MDUFA III performance, three years into the program; a guest column from a former CDRH Office of Compliance director; and more.
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FDA MDUFA III Performance, By The Numbers
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Califf Supports Combo Products Pathway At Confirmation Hearing
FDA's concepts for a new pathway could be ready for congressional scrutiny within a year, Deputy Commission Robert Califf said during his confirmation hearing before the Senate HELP Committee. Most committee members expressed support for Califf's nomination to lead FDA, although he fielded some questions on his ties to industry.
On Eve Of House Hearing, FDA Makes Its Case For LDT Framework
The agency details 20 case studies to support its planned framework for regulating laboratory-developed tests in a report issued the day before a House subcommittee held a hearing on alternative legislative schemes.