Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
In this Bulletin, we highlight some of these findings, which provide a glimpse into FDA’s priority concerns and should help companies proactively and properly plan for their next inspections. To paraphrase from the rock band...more
The Food and Drug Administration recently issued an untitled letter to a medical device company concerning its non-invasive blood test intended for use as a screening tool for the early detection of certain cancer types. FDA...more
Once a month, AGG’s terrific FDA team publishes a newsletter updating readers on the latest regulatory news affecting food/drug companies–including those from Ireland and Northern Ireland. The August newsletter is here and...more
8/27/2015
/ 510(k) RTA ,
Bifurcation ,
Commercial Speech ,
Data Security ,
Evidence ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Free Speech ,
Litigation Hold ,
Medical Devices ,
Off-Label Promotion ,
Pharmaceutical Industry ,
Privacy Policy ,
Sanctions
On July 17, 2015, Georgia’s U.S. Senator Johnny Isakson (R-GA), along with co-sponsors, Robert Casey (D-PA), and Pat Roberts (R-KS), introduced a Senate bill entitled, “The Combination Product Regulatory Fairness Act of...more