The Pharma Data

JUNE 18, 2021

First approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia, 1,2,3,4,5,6,7 including seven responsible for 40% of pneumococcal disease cases and deaths in the U.S. Following today’s FDA approval, the U.S. Jansen, Ph.D.,

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FDA Law Blog: Biosimilars

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. That requirement would only be fulfilled if FDA agreed to such a change. But we digress. And indeed, after Pliva v. billion in damages were brought between 1980 and 1986.

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Agency IQ

JUNE 2, 2023

The FDA first proposed a rule on “Prescription Drug Labeling: Medication Guide Requirements” in 1995 , which was finalized in 1998. However, over the last decade the FDA and other stakeholders have acknowledged that there are opportunities for improvement. Analysis Does a standardized one-page format really work for all drugs?

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The Pharma Data

MAY 16, 2021

Plus, many of these kits claimed to be EU or FDA approved, when they were anything but… Quite simply, they were ILLEGAL, but I was still able to buy them online – and so can you. s one from The Daily Mail in the UK, which was highlighting the risks all the way back in 2007… And very little has changed since then!

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Drug & Device Law

DECEMBER 21, 2023

We’ve been diligently preparing bottom ten annual lists since 2007, even though it’s distasteful, because if we don’t do it nobody else is likely to, and these abominable decisions deserve to be called out for what they are. Holley also allowed a “pre-approval” warning claim to escape preemption, largely on the same rationale.

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Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. Or does it suffice that a vaccine design has been approved in other countries? In Bruesewitz v.

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Drug & Device Law

FEBRUARY 2, 2023

vaccine, this translates into a duty to provide proper warnings in selling the product. 2007 WL 4042757, at *3 (N.D. 15, 2007); McNeil v. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. . . . 3d at 772.

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