article thumbnail

DSCSA’s Wholesale Drug Distributor and Third-Party Logistics Provider Regulations and Preemption of State Laws: Now Dancing on the “Floor” and the “Ceiling”

FDA Law Blog

Preemption of state laws governing not only the tracking and tracing of prescription drugs but also the licensing of WDDs and 3PLs, is a key component of the DSCSA. at least 2-3 years after the rule is finalized) the complicated current state and local license regimes continue. 2) State regulation of third-party logistics providers.–No

article thumbnail

PC for People Experiencing Homelessness: Naheed Dosani

GeriPal

Naheed 15:56 2014. Eric 15:57 2014. I’m guessing, like here, especially in 2014, almost none of it was. Government is not the 51st state. Eric 15:54 What year did you start peach? How much of your training was focused on managing substance use disorder training and palliative care? Naheed 16:05 Yeah, you know.

article thumbnail

Ding Dong is the Skinny Label (Effectively) Dead?

FDA Law Blog

Teva case, that the statutory provisions governing patent infringement, specifically induced infringement, do not address carve-outs. Teva submitted an ANDA in 2002, and after some complicated regulatory history, ultimately carved-out the congestive heart failure indication by way of a section viii statement.

IT 52