FDA Law
JUNE 4, 2025
Ordinarily, a public health initiative of such magnitude would have been governed by a transparent multi-step process featuring public meetings and drawing on external scientific expertise. In other words, as you read this, the Assessments findings and recommendations are getting baked into federal government policy, for better or worse.
FDA Law
JUNE 2, 2023
Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers.
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FDA Law
AUGUST 14, 2022
The negotiations will result in a Maximum Fair Price (“MFP”) that the manufacturer must make available to providers furnishing the drug under Medicare Part B or pharmacies dispensing the drug under Part D. The same will be required under state Medicaid and CHIP programs by October 1, 2023.
Tiny Physician
OCTOBER 17, 2021
On the brighter side, daily case count drastically decreased and vaccination drive is happening at top speed. Almost 1 billion doses of vaccine have been administered so far and the situation is currently under control. If the government wishes to give sugar pills to everyone, let them give candies but not homeopathic pills.
FDA Law
SEPTEMBER 14, 2021
This bill, which addresses numerous areas of the economy, public health, and government regulation, includes Subtitle E, Drug Pricing. The MFP would be established through negotiations between HHS and the manufacturer and would incorporate foreign pricing benchmarks, as further described below. 3, the Elijah E.
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