From 2015 to 2016, FDA appeared to open the door to loosening the standards around intended use and off-label use, but recent rule-making and public comments suggest that FDA is becoming more sclerotic instead of flexible....more
2/20/2017
/ Citizen Petitions ,
First Amendment ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
Labeling ,
Medical Devices ,
Midnight Rules Relief ,
Off-Label Promotion ,
Off-Label Use ,
Pharmaceutical Industry ,
Qui Tam ,
Rulemaking Process ,
Transition Team ,
Trump Administration
On Monday, FDA issued a final rule to amend FDA’s established definitions of “intended use” for drugs and devices, the primary consideration in determining whether a product is regulated for a particular use and what...more
As we noted in our December 9th post, the 21st Century Cures Act (the “Cures Act”) requires FDA to develop a framework and guidance for evaluating real world evidence (“RWE”) in the context of drug regulation to support...more
As we’ve previously reported, FDA has recently been forced to reexamine its legal position and enforcement policies related to drug and device manufacturers’ off-label communications. Although the Agency has for years...more
In recent years, applications for orphan drug designations have flooded into FDA at a rapid pace, and this year appears to be no exception. Orphan drug applications received by FDA rose by approximately 30% over the previous...more