Information Manufacturing Provider Vaccination 
FDA Law
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
HB 2 – Vaccine Consent What’s in the Bill: Sponsored by Rep. Under current law, minors aged 14 or older are permitted to consent to vaccines (excluding the Covid Vaccine) for themselves without parental consent. The bill also addresses parental access to health information and parental rights.
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FDA Law
SEPTEMBER 30, 2024
CMS did not finalize the price verification survey, which would have required manufacturers of 10 costly drugs selected annually to provide clinical information as well as information on production, distribution, research, and marketing costs, revenue and profit, and ex-U.S. pricing, among other things.
FDA Law
OCTOBER 24, 2024
Gibbs — A recent blog post focused on the potentially negative implications of the proposed Patent Eligibility Restoration Act (PERA) for manufacturers of generic drugs and biosimilar products. They argued that the legislation was necessary to spur innovation of new vaccines and therapies in response to emerging health threats.
FDA Law
JUNE 2, 2023
Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers. Price Transparency Surveys The MDRP statute requires manufacturers to submit only three prices: average manufacturer price (AMP), best price, and nominal prices.
FDA Law
AUGUST 21, 2023
After all, the labeling is intended to do exactly that: it informs patients and prescribers of the risks to ensure the product is used effectively and in a manner that mitigates risks, according to FDA’s understanding of the relevant science.
FDA Law
APRIL 7, 2025
Elanco is the manufacturer of recently approved Zenrelia (ilunocitinib tablets) (September 2024), which is indicated for control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. Further, information presented on the adverse reaction data was inconsistent with the PI.
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