News

Summary of Hematology and Pathology Devices Panel Meeting

A summary of speeches and events. Read more

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. Read more

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. Read more

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. Read more

510(k)s Are on the Hot Seat!

FDA is in the cross-hairs again. Expect new legislation from Congress in the upcoming administration, and perhaps a complete overhaul of the device review process but until this is sorted out, expect more delays while FDA tries to fight off allegations, clean up internally and make case-by-case decisions as to which devices are “high risk” and require more clinical data. Read more