FDA Law Blog

JANUARY 15, 2024

FDA , Petitioners, a liquid nicotine manufacturer, sued FDA arguing that the Agency was arbitrary and capricious in rejecting the Petitioner’s Premarket Tobacco Application (“PMTA”) in violation of the Administrative Procedure Act (“APA”). FDA also directed manufacturers to produce detailed marketing plans.

Manufacturing 115

Manufacturing IT Provider ER 115

Common Sense Family Doctor

FEBRUARY 15, 2025

In 1998, a Letter to the Editor in American Family Physician expressed concerns about the relatively new practice of pharmaceutical advertising directly to patients. The annual price of risankizumab is $288,000, so this is still a huge bargain for the company given the potential returns. Kennedy, Jr.’s

Family Physician 40

Family Physician Manufacturing Family Families 40

GeriPal

MARCH 2, 2023

AFP 2019 Gabapentin for chronic neuropathic pain in adults. And for that reason, there was actually an enormous lawsuit, and the manufacturer was fined, now I think 20 years ago, in the millions and millions of dollars for off-label prescribing. These are families who are in distress. But yes, they’re both increasing.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96