QSR Inspection Strategy To Focus On Four "Subsystems," FDAer Says
This article was originally published in The Gray Sheet
FDA's revised quality systems inspections strategy will instruct investigators to focus on four of the seven major elements in the agency's quality systems regulation, FDA GMP/Quality Systems Expert Kim Trautman said at an April 29 videoconference sponsored by the Food & Drug Law Institute.
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.