FDA Law Blog: Biosimilars

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”). covered insulin product or vaccine). 1395w-114c(b)(4)(B)(i). state pharmaceutical assistance programs).

Compliance 105

Compliance Drugs Pharmacy Licensing 105

The Pharma Data

MAY 14, 2021

Like many other hyperhidrosis sufferers, I assumed that hyperhidrosis was a temporary thing so it was obviously very frustrating when my hyperhidrosis only worsened with age–despite my determination to get rid of the problem, my constant trips to the doctor and pharmacies, and thousands of dollars spent on hygiene products.

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Doctors Production Pharmacy Vaccine 52

The Pharma Data

MAY 14, 2021

I have a cure for hives and angioedema! It is a natural cure which means it cannot be registered as a patent thus it cannot be marketed using the regular channels (drug industry-pharmacies etc.). Let’s see a pharmacy or doctor top that! Let’s see a pharmacy or doctor top that! Let’s see a pharmacy or doctor top that!

Treatment 52

Treatment Doctors Pharmacy Production 52

Drug & Device Law

DECEMBER 29, 2023

Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. Not surprisingly, the daughter suffered no injury at all from being vaccinated. Preemption.

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Testimonials Drugs FDA Vaccine 105

Drug & Device Law

MARCH 30, 2023

About two months ago, we marveled at the notion that challenges to facially neutral state and local government vaccine requirements were still percolating through the legal system. 552 (2011), and especially in the months after the Supreme Court revisited the subject of content-based speech restrictions more generally in City of Austin v.

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Vaccine Pharmacy FDA Treatment 75

Drug & Device Law

FEBRUARY 20, 2023

For several decades – starting with plaintiffs’ pre-Vaccine Act attacks on vaccine designs – courts have addressed FDA approval as a component of “feasibility” in states that impose this limitation on design defect claims. Or does it suffice that a vaccine design has been approved in other countries? In Bruesewitz v.

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FDA FDA Approval Testimonials Vaccine 59