FDA Law

DECEMBER 12, 2023

We know what you must be thinking: “With all this crystal formation, why don’t they call them Glitter boxes?” (Apologies to our readers—word play is FDA Law Blog’s catnip.) RSS is a measurement used to estimate the potential for crystal formation and bladder stone (urolith) growth, a common affliction in cats. Upper bound of 95% CI ≤ 2.5

Utilities 59

Utilities Manufacturing Provider Individual 59

FDA Law

NOVEMBER 6, 2022

Gaulkin — We previously blogged about Pfizer’s copay assistance lawsuit, which sought to challenge HHS’s interpretation of the Federal health care program anti-kickback statute (AKS) and position that the company’s proposed copay assistance program would violate the AKS. By Sophia R. Background. Pfizer’s Petition to SCOTUS.

Manufacturing 83

Manufacturing Patient-Centered Healthcare Utilities 83

FDA Law

SEPTEMBER 20, 2021

Some of these will be subjects of more detailed posts in the future and readers should keep an eye on the blog for additional coverage. 30, 2023; Public workshop on advancing innovative manufacturing technology, by end of FY 2023; Publish advancing innovative manufacturing technology strategy document, by Sept.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law

JANUARY 26, 2022

By Dara Katcher Levy — We are working to keep up with OPDP’s posts over the past few weeks and a blog on its most recent letter to Lilly is forthcoming! In defending the complete broadcast, Lilly called out similar elements from each of the individual components as demonstrating its intent to have all three viewed sequentially.

IT 40

IT Education Utilities Patient-Centered 40

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.

Manufacturing 59

Manufacturing Vaccination Government Diagnosis 59

FDA Law

AUGUST 21, 2023

Further, FDA has utilized a variety of strategies to call attention to safety issues through Dear Doctor letters or other forms of communication, even if directing changes to labeling is difficult. Most OTC drugs, particularly drugs that have been around for a while, are primarily marketed pursuant to OTC monographs.

Manufacturing 40

Manufacturing Consulting Healthcare Professional Vaccination 40