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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Neurological devices panel: FDA's neurological devices advisory panel will meet Nov. 20 to vote on a PMA for Medtronic's deep brain stimulation system for treating epilepsy. The device is intended as an adjunct to drugs for reducing the frequency of seizures in patients with drug-refractory epilepsy with partial-onset seizures. Medtronic announced in July it had filed the PMA, supported by data from a trial showing reduced seizure frequency in the DBS group compared to patients taking medication alone (1"The Gray Sheet" July 20, 2009). Medtronic has marketed the Activa DBS system for Parkinson's and essential tremor for more than a decade and also recently gained an humanitarian device exemption for obsessive-compulsive disorder DBS therapy and is pursuing a depression indication

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Regulatory News In Brief

FTC advertising guides: Revised final 1guidance from the Federal Trade Commission, effective Dec. 1, tightens up the commission's guidelines for using endorsements and testimonials in advertising, including blog posts. Under the revisions, when ads portray a consumer whose experience with a product is not typical, the advertiser must also disclose what results can generally be expected. The "results not typical" disclaimer is no longer allowed. Endorsers are also liable for false or unsubstantiated claims, or for failing to disclose financial ties with the advertiser, FTC clarifies. New examples address, among other things, what constitutes an endorsement in a blog post. Also, if a company references a research organization's findings from a company-sponsored study, the ad must convey that connection, the commission noted. FTC's endorsements and testimonials guides were last updated in 1980

Regulatory News In Brief

FTC advertising guides: Revised final 1guidance from the Federal Trade Commission, effective Dec. 1, tightens up the commission's guidelines for using endorsements and testimonials in advertising, including blog posts. Under the revisions, when ads portray a consumer whose experience with a product is not typical, the advertiser must also disclose what results can generally be expected. The "results not typical" disclaimer is no longer allowed. Endorsers are also liable for false or unsubstantiated claims, or for failing to disclose financial ties with the advertiser, FTC clarifies. New examples address, among other things, what constitutes an endorsement in a blog post. Also, if a company references a research organization's findings from a company-sponsored study, the ad must convey that connection, the commission noted. FTC's endorsements and testimonials guides were last updated in 1980

Deep brain stimulation

Medtronic has filed a PMA for its deep brain stimulation therapy for patients with medically refractory epilepsy with partial-onset seizures. The application is supported by data from the randomized, double-blind Stimulation of the Anterior Nucleus of the Thalamus in Epilepy (SANTE) trial. Results presented in December at the American Epilepsy Society meeting showed that patients receiving DBS therapy in the left and right anterior nucleus of the thalamus, in conjunction with epilepsy medication, had significantly reduced seizure frequency compared to those receiving no stimulation (1"The Gray Sheet" Dec. 15, 2008). Medtronic has marketed the Activa DBS system for Parkinson's and essential tremor for more than 10 years

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