Bill of Health

NOVEMBER 29, 2023

By Vincent Joralemon Spravato, the first FDA-approved psychedelic therapy, just outsold Viagra. Pfizer’s successful clinical trials for ED followed, leading to FDA approval of sildenafil citrate, marketed as “Viagra,” in 1998. This became Spravato, the first FDA-approved psychedelic therapy. Initially, the public is hesitant.

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SQA

AUGUST 1, 2024

Consequently, the Inspection Review Group at the MMA decided to issue a Statement of Non-Compliance with the principles and guidelines of GMP laid down in Directive 2003/94/EC for the site, reflecting ongoing concerns about compliance and quality management at Cubit Lifesciences. Kappin Ltd.

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Drug & Device Law

JANUARY 4, 2024

That Complaint alleges various antivax conspiracy theories concerning COVID-19 vaccines, the FDA, emergency use authorizations, and the media that have circulated since these vaccines first became available. The FDA, however, did not and does not share that belief. FDA (8/23/21) press release (emphasis original).

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Drug & Device Law

MAY 26, 2023

We are not looking do either of those, but we will weigh in on what NPP means for non-product liability cases involving FDA-regulated medical products. A hundred years later, we detailed three rounds of litigation over Massachusetts’ serial efforts to ban, or at least substantially limit, the use of FDA-approved pain medications.

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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. Are manufacturers liable only for failing to employ an alternative design that the FDA has approved for distribution. . .

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