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Tobacco Products Scientific Advisory Committee (TPSAC) meeting 3-1-2012

On March 1st, 2012, the Tobacco Products Scientific Advisory Committee met to finalize their report on dissolvable tobacco products, and their impact in several areas including public health and on children’s health. Background:  The TPSAC is an advisory panel within the FDA that was created by the Family Smoking Prevention and Tobacco Control Act (Public [...]

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IVD Roundtable Notes

December 8, 2011 John Kahan of Hogan & Hartson gave an introductory speech. He pointed out that his firm represents over 700 device companies, work with every different division/office in CDRH, and that in his opinion, CDRH (including OIVD) has been behaving generally different from past years. Policies at CDRH have been changing, and the [...]

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Summary of Hematology and Pathology Devices Panel Meeting

A summary of speeches and events.

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IVD Roundtable at the FDA, Jan. 13, 2010

At the FDA, the OBRR Director Jay Epstein welcomed us and introduced the first speaker, Sayah Nedjar, who gave us a CBER update.

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Marketing drugs or devices to health care providers? The national legal trend is “no more tchotchkes”.

As of today, seven states and the District of Columbia have enacted laws addressing marketing practices of pharmaceutical manufacturers, in terms of gifts and perks provided to their customers.

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Summary impressions of the IVD roundtable meeting held on December 11, 2008, from 9 am to 4 pm, at OIVD, FDA

These are the highlights of the meeting.

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