The U.S. Food and Drug Administration (FDA) makes available guidance for industry and staff titled “Molecular Diagnostic Instruments with Combined Functions.” The document sets forth the agency’s “current thinking on regulation of molecular diagnostic instruments both approved/cleared device functions and device functions for which approval/clearance is not required, and on the type of information that FDA recommends that applicants include in a submission for a molecular diagnostic instrument that measures or characterizes nucleic acid analytes and has combined functions.”
The U.S. Food and Drug Administration seeks comments on the estimated time burdens for industry to maintain standard operating procedures and keep records required under the agency’s current good manufacturing practice regulations for finished pharmaceuticals. Comments are requested by January 9, 2015.
The U.S. Food and Drug Administration seeks comments on research titled “Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in DTC [direct-to-consumer] Prescription Drug Ads.” The agency describes the study protocol, estimates reporting burdens and, among other matters, asks for comments on “ways to enhance the quality, utility, and clarity of the information to be collected.” Comments are requested by January 12, 2015.
The U.S. Patent and Trademark Office (USPTO) announces a December 2, 2014, roundtable and requests comments “on USPTO use of crowdsourcing to identify relevant prior art” to enhance the quality of patent examination and issued patents. Those wishing to participate as speakers must submit written notice by November 18, and those wishing to attend the roundtable in person or via Webcast must register by November 25. Written comments are requested by December 9. The December roundtable follows an April 2014 event that “focused on the use of crowdsourcing and third-party preissuance submissions to identify relevant prior art”; materials from that roundtable are available online.