by Marc Kleinman | Mar 12, 2012
In recent years, all the talk in the medical device community has been about the VC funding reservoir for biotechs and medtechs going dry. But according to VentureDeal.com, H2 2011 saw some major deals for medical device companies, featuring investments from many of...
by Marc Kleinman | Mar 1, 2012
18 months after opening its draft guidance to public comment, FDA has published its final industry guidance for chemistry, manufacturing, and control (CMC) information in early clinical trials with live biotherapeutic products (LBPs). The guidance outlines the CMC...
by Marc Kleinman | Feb 29, 2012
FDA recently published a warning letter (dated June, 2011) to a virtual drug and device firm based in North Carolina, citing several quality concerns. Chief among the issues raised by FDA was the firm’s failure to establish a quality agreement with the contract...
by Marc Kleinman | Feb 23, 2012
FDA recently announced that it intends to “vigorously enforce requirements” relating to postmarket studies and clinical trials for approved drugs. Among the many provisions of the 2007 FDA Amendments Act (FDAAA), is the expanded authority of the Agency to enforce...
by Marc Kleinman | Feb 23, 2012
The recently-released FDA report entitled, “[FDA] Transparency Initiative: Exploratory Program to Increase Access to the Agency’s Compliance and Enforcement Data,” announced 8 new initiatives adopted as part of FDA’s Transparency Initiative, launched in 2009 by...
