12
Dec

Revision 1 of Risk information in Promotional Materials and Ads Hits the Street 

Yesterday, the FDA issued the first revision of the Guidance titled Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements (here).  This Guidance covers the following four topics:  Providing quantitative efficacy or risk information for the control group, when applicable;  Presenting probability information in terms of absolute frequencies, percentages, and relative […]

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29
Nov

That DRESS Could Be Life Threatening! 

The FDA is warning about a serious and potentially fatal adverse event that has been reported with use of the antiseizure medications levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan).  The ADE, called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), is extremely rare and the “FDA’s cumulative review found 42 serious […]

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22
Nov

A New Wave of Warnings for Pain Relief Products with Hidden Drug Ingredients 

Just like the FDA says on its warnings and notifications page (here):  “It is clear from the results of our decade of testing that retailers and distributors, including online marketplaces, do not effectively prevent these types of potentially harmful products from being sold to consumers. FDA cannot test all products on the market that contain […]

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20
Nov

Happy Thanksgiving Y’all! 

This has been a tough year for pharmaceutical companies, with price concerns on the tip of everyone’s tongue, the race to the bottom on generic drug pricing and its impact on drug shortages, FDA now back almost fully in the facility inspection mode, Warning Letters flying out of the Agency at a breakneck pace, and […]

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20
Oct

Animal Drug User Fees for FY 2024 Just Howled Out Today!

On September 30, 2023, the Animal Drug and Animal Generic Drug User Fee Amendments of 2023 were signed into law as part of H.R. 5860.  The amendments reauthorize the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA) programs administered by the U.S. Food and Drug Administration until 2028. But not […]

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04
Oct

Chipping Away at 180-day Exclusivity:  A Good Discussion 

In a rousing session at the AAM’s GRx-Biosims conference, Kurt Karst, J.D., Director, Hyman, Phelps & McNamara, Brian McCormick, J.D., M.H.S., Vice President and Chief Regulatory Counsel, Teva Pharmaceuticals, and Chad Landmon, J.D., Partner, Axinn, Veltrop & Harkrider LLP gave a presentation entitled 180-Day Exclusivity: What Is Past Is Prologue or, as they like to […]

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