Agency IQ

SEPTEMBER 15, 2023

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. The FDA will follow these procedures for both agency-initiated operations (e.g.,

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Science FDA Clinical Trials Pharmacy 40

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). & Com.

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Vaccine FDA FDA Approval Pharmacy 59

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. to determine whether a proposed alternative drug would have received FDA approval.” at 237-38.

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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 state cannot regulate commerce occurring wholly outside its borders. The most prominent litigation in this space these days relates to reproductive rights. Ogden , 22 U.S.

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