Remove 2014 Remove Complication Remove Government Remove Provider
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

As the drug distribution industry is well aware, and as blogged about here , on February 4, 2022, FDA published its long-awaited proposed rule titled “ National Standards for the Licensure of Wholesale Drug Distributors and Third-party Logistic Providers ” (87 Fed. 2) State regulation of third-party logistics providers. 6,708 (Feb.

article thumbnail

PC for People Experiencing Homelessness: Naheed Dosani

GeriPal

link] PEACH Good Wishes Program A program that provides meaningful gifts for unhoused individuals who are terminally ill. They can’t believe it, but we come back again and again and again gently to provide that support. And so the attitude has unfortunately become like, we just don’t provide care to folks.

article thumbnail

Ding Dong is the Skinny Label (Effectively) Dead?

FDA Law Blog

Though the carve-out seems at odds with FDA’s regulations requiring generic drugs to have the “same labeling” as their RLDs, such regulations specifically provide for differences arising from carved-out, patent-protected method of use. The catch is, as we have learned from the GSK v. Teva decision changed everything.

IT 52