Skinny Labeling

31
Mar

The Skinny Label Gets Some Food for Thought that May Fatten Up Its Standing

I’ve been blogging about the chilling and hugely negative impact that the court decisions in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., No. 18‑1976, have on the delicate balance between the generic and brand‑name industries struck by the Drug Price Competition and Patent Term Restoration Act of 1984 (better known as the Hatch-Waxman Act).  I won’t recount the […]

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10
Mar

FDA 2024 Budget Proposal Proposes Fix to the “Skinny” Label Issue

The FDA released its proposed budget and legislative proposals for FY 2024 (summary can be found here).  Besides certain requests for additional funding, reauthorization of the user fee programs for new and abbreviated animal drug programs, a host of safety issues, as well as new record retention requirements to fight data integrity problems in applications and […]

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12
Jan

Saving the Skinny Label: Could Another Case Bring It Off the Respirator?

This morning, Sara W. Koblitz of Hyman, Phelps & McNamara posted a blog titled “Is The Skinny Label Back From the Dead?” (here) that suggests there may be hope for the skinny label after all.  The blog details the GSK v. Teva decision and the potential dire implications for the skinny label.  She also outlines […]

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04
Jan

Kick, Fight, and Scream, but Most of All Hope the Full Appeals Court (and/or the Supreme Court) Reverses

Ever since November 24, 1984, the effective date of the Drug Price Competition and Patent Term Restoration Act (aka Hatch-Waxman) which created the unique and delicate balance between innovation and safe and effective high quality generic copies of brand name products, the use of the “skinny label” has been a touchstone of that balance.  Rather […]

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