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. After all, companies already have FDA-approved labels.

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Agency IQ

MARCH 7, 2024

This follows a contentious April 2023 meeting of FDA’s Anesthetic and Analgesic Drug Products Advisory Committee, at which the committee members raised serious concerns about the methodology of such a study and did not support its utility for a post-marketing requirement (PMR).

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Advarra

DECEMBER 14, 2022

Effective as of 2007, Medicare has offered coverage for routine costs in clinical trials. FDA-approved IDE devices may be deemed qualifying under the Medicare Benefit Policy Manual, Chapter 14. The investigational agent in the trial has an FDA-issued investigational new drug (IND) approval and associated six-digit number.

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Codon

FEBRUARY 23, 2025

Zidovudine showed promise against multiple HIV strains in cultured cells, and the Food and Drug Administration (FDA) approved it for human studies within five months. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. In South Africa, there are about 150,000 new HIV infections each year.

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Drug & Device Law

FEBRUARY 22, 2024

This “keep selling” theory found some traction in two 2007 decisions, Abigail Alliance for Better Access to Developmental Drugs v. 2007) (en banc), and CareToLive v. Ohio 2007), but has generally failed to expand that foothold since. von Eschenbach , 495 F.3d 3d 695 (D.C. von Eschenbach , 525 F. 2d 952 (S.D.

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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

MAY 26, 2023

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. For instance, Sorsaia primarily involves a challenge to a state trying to prevent in-state use of an FDA-approved drug for its FDA-approved use.

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Drug & Device Law

MAY 19, 2023

The core premise of Bexis’ article is very simple: Once the FDA has said “yes” and approved a particular drug for a particular indication (“intended use”) for sale in the United States, federal preemption precludes any state from saying say “no” and trying to ban that same FDA-approved drug. In GenBioPro, Inc.

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Drug & Device Law

FEBRUARY 20, 2023

In product liability litigation generally, plaintiffs have been allowed to invent all kinds of “alternative” designs as long as some “expert” opines that the design (even if never before marketed) is “feasible.” Are manufacturers liable only for failing to employ an alternative design that the FDA has approved for distribution. . .

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Drug & Device Law

FEBRUARY 2, 2023

1974) (applying Texas law), the Fifth Circuit had held: [T]o conclude that the maker of an unavoidably unsafe product did not act unreasonably in placing it on the market is not to relieve him of the responsibility to market it in such a way as to prevent unreasonable danger. 2007 WL 4042757, at *3 (N.D. 15, 2007); McNeil v.

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Drug & Device Law

JUNE 2, 2022

2012), addressed a challenge to the application of Idaho’s Pain-Capable Unborn Child Protection Act to criminalize the use of an FDA-approved abortifacient medication obtained through an internet prescription and mailed to the plaintiff from out of state. 124 (2007), which would also be knocked out by Dobbs if it sticks.

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Drug & Device Law

MARCH 31, 2022

We discussed these concerns – which have since crystallized into what is called either the “municipal cost recovery rule” or the “free public services doctrine” – more detail back in one of the Blog’s early(2007) posts. In other words, the generic manufacturers are not allowed to change the FDA-approved label. E.g , Morris v.

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