DCRND GROUP LEADERS GET 510(K) CLEARANCE AUTHORITY UNDER REORGANIZATION
This article was originally published in The Gray Sheet
DCRND GROUP LEADERS GET 510(K) CLEARANCE AUTHORITY UNDER REORGANIZATION of the Division of Cardiovascular, Respiratory, and Neurological Devices in FDA's Office of Device Evaluation. The 120-day pilot restructuring, implemented Sept. 1, gives leaders of four device review groups authority to sign off on all documents related to 510(k) decisions with the exception of not substantially equivalent (NSE) letters, which will still require the signature of DCRND Director Thomas Callahan. Previously, the DCRND director also signed off on standard substantial equivalence decisions and other documents such as "special routine letters" and 510(k)s with "unique responses."
You may also be interested in...
FDA action awaits Sun’s manufacturing facility in Halol after it failed to adequately address GMP deviations, though India’s top-ranked drug firm appears to have effectively lowered its dependence on the site that has had a patchy compliance run.
In a surprise to the market, Dr Reddy’s and Hikma have prevailed in challenging six method-of-use patents shielding Amarin’s Vascepa in the US, opening the door for a potential at-risk launch that would likely be challenged by the originator.
Duo will study up to four novel preclinical targets identified by Sitryx that may lead to potential new drugs for autoimmune diseases, which Lilly would then commercialize.