By Peter S. Reichertz
On August 9, 2010, the Food and Drug Administration (“FDA”) published a notice announcing a public meeting to be held September 17, 2010, “to gather stakeholder input on the development of a generic drug user fee program.” See 75 Fed. Reg. 47,820-21. FDA also requested submission of written comments on issues relating to assessment of user fees for generic drugs, which can be submitted by no later than October 17, 2010.
By Peter S. Reichertz, Brian D. Weimer and Daniel Brooks
Last week, the Federal Communications Commission ("FCC") and the Food and Drug Administration ("FDA") launched a joint initiative to clarify the approval process and regulatory requirements for converged communications and health care devices. In a two-day joint meeting held on July 26-27, 2010, the two agencies solicited comments from industry representatives "to gain a better understanding of the convergence of communications technologies and medical devices, the future of wireless health technologies, and the challenges they face." The goal of the initiative is "to enhance coordination between FDA and FCC for future devices and applications, and to clarify and delineate the respective areas of expertise and jurisdiction between the agencies."
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