The Institute of Medicine committee charged with reviewing FDA's 510(k) device pre-market review program is urging the agency to ditch the 35-year-old program and start fresh.

LaViolette joins valve developer board: Former chief operating officer and soon-to-be former senior advisor to Boston Scientific Paul LaViolette last week joined the board of directors of privately held Direct Flow Medical, which is developing a minimally invasive aortic valve replacement system. Edwards Lifesciences has the only transcather valve product on the market (in Europe), but several other large firms, including Medtronic and Johnson & Johnson, are developing such products. LaViolette had been with Boston Scientific for 15 years, but is slated to leave the company at the end of the year following a reorganization announced in June (1"The Gray Sheet" June 9, 2008, p. 8)

Amneal is close to a filed pipeline of three biosimilar products in the US, while furthering ambitions in the complex generics and 505(b)(2) space, management told the virtual J.P. Morgan Healthcare Conference.