FDA Law

OCTOBER 1, 2024

Or consider Vanda’s challenge that FDA’s approval of a generic version of one of the company’s drugs violated the Appointments Clause of the Constitution (U.S. Murphy, Director of the Office of Generic Drugs’] ratification cured any Appointments Clause deficiency because it is unclear whether any statute properly authorized her appointment.

Government 59

Government Appointment IT Manufacturing 59

FDA Law

JUNE 14, 2023

This is about reducing the time and cost and increasing the predictability of going from concept to commercialization.” – Dr. Jeff Shuren During a presentation at the May 17, 2023 Food and Drug Law Institute (FDLI) Annual Conference, CDRH Director, Dr. Jeff Shuren discussed TAP with enthusiasm.

Manufacturing 45

Manufacturing Medical Appointment Patient-Centered 45

FDA Law

JANUARY 24, 2024

Fast-forward to March 2023, when The White House OSTP issued a document per Executive Order 14081, titled “ Bold Goals for U.S. That’s a pretty lofty API manufacturing goal, but one that the API Innovation Center (“APIIC”) was charged to take up, consider, and propose some possible solutions. And so in November 2023 in St.

Supply Chain 69

Supply Chain Manufacturing Government Provider 69