FDA Law

OCTOBER 24, 2024

Gibbs — A recent blog post focused on the potentially negative implications of the proposed Patent Eligibility Restoration Act (PERA) for manufacturers of generic drugs and biosimilar products. They argued that the legislation was necessary to spur innovation of new vaccines and therapies in response to emerging health threats.

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FDA Law

JUNE 2, 2023

Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers. Price Transparency Surveys The MDRP statute requires manufacturers to submit only three prices: average manufacturer price (AMP), best price, and nominal prices.

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FDA Law

JANUARY 3, 2024

CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA). The unapproved drug claims are not, in and of themselves, notable, but it is always interesting when FDA takes a stand against such a large swath of manufacturers and distributors at the same time.

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FDA Law

AUGUST 21, 2023

Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target. This is because the presumption that manufacturers can unilaterally make substantive changes to the labeling of an OTC Monograph drug product is false.

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FDA Law

MAY 15, 2025

He spoke with obvious enthusiasm about the recently announced pilot AI-assisted review and its potential to shave weeks off approval timelines, as he described hearing from one reviewer in the pilot project who said the pilot AI tool completed three days work in gleaning salient facts from medical literature in six minutes.

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FDA Law

JUNE 4, 2025

There are also drugs the Assessment identifies as being used off-label without high-quality evidence or for uses that are approved but without rigorous true placebo-controlled trials (namely vaccines) and/or with known safety concerns. We will continue to monitor these developments as they come.

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FDA Law

FEBRUARY 4, 2025

Our colleagues have recently blogged about the RPD PRV here and here , its four-year sunset date, and the political drama that it frequently gets caught in. The authors suggested that the developers of such therapies would receive a priority review voucher that they can sell to manufacturers of blockbuster drugs.

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