FDA Law

NOVEMBER 16, 2021

1) publish a list of selected drugs in accordance with section 1192; (2) enter into agreements with manufacturers of selected drugs with respect to such period, in accordance with section 1193; (3) negotiate and, if applicable, renegotiate maximum fair prices for such selected drugs, in accordance with section 1194; and. (4)

Manufacturing 52

Manufacturing Government IT Complication 52

FDA Law

JUNE 7, 2023

Recall that CMS will require manufacturers of selected drugs to negotiate a maximum fair price (“MFP”) with the agency according to the following timeline (the dates apply from applicable year 2027 onwards). N/A June 30 The manufacturer must accept the price or counteroffer—with a rationale. Complaint at 2.

Manufacturing 45

Manufacturing Government IT Provider 45

FDA Law

MARCH 5, 2024

In granting the Government’s summary judgment motion, the court held that AstraZeneca did not have the requisite standing for the APA arguments because it failed to identify a cognizable injury-in-fact that could be redressed by vacatur of the Guidance. Opinion at 17.

Government 64

Government IT Manufacturing Illness 64

FDA Law

JUNE 27, 2022

If and when implemented, the amendments will likely force Medicare Part D plans and their PBMs to pass drug manufacturer rebates through to pharmacies to reduce out-of-pocket expenses of Part D enrollees, which would be a dramatic change from current practice.

Finance 52

Finance Government Manufacturing Community 52