Agency IQ

JULY 26, 2024

BY AMANDA CONTI | JUL 24, 2024 9:57 PM CDT Background: Modernizing regulation of over-the-counter (OTC) products Nonprescription products, also called over-the-counter (OTC) products, must demonstrate the ability to be used safely and effectively without the supervision of a qualified healthcare professional.

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Agency IQ

NOVEMBER 10, 2023

The delayed enforcement is part of FDA’s finalized guidance, “Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing.” NOV 8, 2023 10:02 PM CST Regulatory background The Federal Food, Drug, and Cosmetics Act (FD&C Act) is administered by the Food and Drug Administration (FDA) and regulates cosmetics.

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Agency IQ

JUNE 2, 2023

BY ALEXANDER GAFFNEY, MS, RAC, LAURA DIANGELO, MPH MAY 30, 2023 9:39 PM CDT Regulatory background and context The FDA uses various controls, including labeling and warnings, to ensure that medical products are used appropriately and safely. The FDA recently concluded its work on a proposed rule focused on PMI.

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Agency IQ

MAY 31, 2024

Shield is already available as a laboratory developed test (LDT), which allowed the sponsor to utilize a unique data set: Adherence The PMA for the Shield blood test was submitted to FDA in May 2023. Analysis & What’s Next Up front, the advisory committee panel meeting touched on several hot topics in diagnostics regulation.

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Agency IQ

MARCH 7, 2024

BY LAURA DIANGELO, MPH | MAR 6, 2024 5:54 PM CST Fiscal year 2024 appropriations bills On March 3, 2024, House and Senate appropriators released a package of final fiscal year (FY) 2024 appropriations bills. Per the budget table , this is actually a (relatively) small decrease for the FDA. AgencyIQ has the highlights.

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Drug & Device Law

DECEMBER 29, 2023

In 2023 there seemed to be an unusually large number of other decisions that are likely to have a substantial impact on what we or our clients do, but involve either different products, non-product claims, or both. In 2023, these include United States ex rel. 2023) (no medical monitoring in Delaware) ( here ); Brown v.

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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). & Com.

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Drug & Device Law

AUGUST 3, 2023

22-2212, 2023 U.S. July 24, 2023), we see the appeal of the dismissal of dozens of plaintiff’s claims against a generic manufacturer of amiodarone, which has featured in a number of generic drug preemption decisions over the years. Plaintiffs did not even complain about the content of the package insert. Bartlett , 570 U.S.

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Drug & Device Law

MAY 4, 2023

1:21-cv-700, 2023 WL 3075403 (S.D. 25, 2023), is one we have been talking about for a long time. 2015), finally gave appellate recognition to the preemption of design defect claims for FDA-approved branded prescription drugs. 2023 WL 3075403, *3. Pacira Pharms., As detailed here , the decision in Yates v.

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