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Free speech can wait?

Executive Summary

FDA should extend the timeline for responses to a request-for-comment on First Amendment issues, Pfizer and the Pharmaceutical Research & Manufacturers of America tells the agency. "As an institutional matter, Pfizer is committing substantial time and resources to reviewing and responding to the notice," the company said. "Pfizer intends to consult with various experts concerning many of these questions to prepare more fully informed comments." FDA asked for comments by July 30 on the legal basis for its promotional rules with another 45-days for rebuttals (1"The Pink Sheet" May 20, p. 14). PhRMA and Pfizer are asking for a 60-day extension, which would move the final deadline back until the week after Election Day...

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Free speech comment deadline extended

FDA grants 45-day extension for comments on First Amendment issues and agency regulation of commercial speech. Comments will be due Sept. 13, rebuttal comments Oct. 28. The extension comes "in response to several requests from the public," agency says. Pfizer and Pharmacia are among those who asked FDA for additional time; the companies requested a 60-day extension (1"The Pink Sheet" Jun. 24, In Brief). FDA solicits comments on free speech in July 3 Journal of the American Medical Association "News and Analysis" section...

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QUOTED. 28 January 2020. Steven Falowski.

Abbott is encouraged by results from two studies of its Proclaim XR neurostimulation system for chronic pain, presented at the annual North American Neuromodulation Society (NANS) meeting in Las Vegas. See what Steven Falowski of Neurosurgical Associates of Lancester in Pennsylvania said about it here.




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