FDA Law Blog
DECEMBER 3, 2023
As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028.
Alabama Academy of Family Physicians
FEBRUARY 19, 2025
As the 2025 legislative session swings into full gear, the Alabama Academy of Family Physicians (AAFP) has set its sights on a cadre of pivotal bills set to shape the healthcare landscape for years to come. HB 2 – Vaccine Consent What’s in the Bill: Sponsored by Rep.
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FDA Law Blog
FEBRUARY 4, 2025
Koblitz Last December, Congress narrowly avoided a shutdown by significantly paring down the originally proposed 2025 Appropriations bill, slashing away hundreds of programs and laws. The authors suggested that the developers of such therapies would receive a priority review voucher that they can sell to manufacturers of blockbuster drugs.
FDA Law Blog
APRIL 7, 2025
Lets take a look at these letters: Back in January 2025, CVM issued a Warning Letter to animal drug sponsor Elanco Animal Health. Zenrelia comes with serious warnings, including a boxed warning against the use of Zenrelia during vaccination. that it is effective on Day 1) and insinuating misleading comparative claims.
Alabama Academy of Family Physicians
FEBRUARY 20, 2025
cases in 2024-2025, H5N1 disease in humans had a high mortality rate of up to 50%. Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed. To date, more than 160 million poultry are known to have been affected. Prior to the current U.S. However, the 68 human cases in the U.S.
FDA Law Blog
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.
Doctors for America
MAY 15, 2025
FOR IMMEDIATE RELEASE Doctors for America PO Box: 21161 2300 18th St NW Lbby Washington, DC 20009-9996 May 15, 2025 Doctors for America’s FDA Task Force Dismayed by Kennedy Testimony WASHINGTON, D.C. The standard response of activating the public health officers to educate, engage and vaccinate did not happen due to funding cuts.
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