FDA Law

AUGUST 4, 2022

Pfizer manufactures tafamidis, a breakthrough treatment for a rare, progressive heart condition known as transthyretin amyloid cardiomyopathy. Eligible patients would be responsible for only $35 per month, and Pfizer would cover the rest of the approximately $13,000 annual copay. Background. The Lesson of this Case.

Manufacturing 98

Manufacturing Medical Government IT 98

FDA Law

SEPTEMBER 11, 2023

This announcement addresses one of the commitments in FDA’s Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health. Over the years, we’ve blogged on similar initiatives related to the 510(k) pathway. In a statement released at the time, CDRH Director Jeffrey Shuren, M.D.,

Medical 64

Medical Electronics Manufacturing Utilities 64

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

JULY 17, 2022

Kirschenbaum — Last November, we blogged about a provision of the Infrastructure Investment and Jobs Act that requires new rebates for discarded amounts of drugs that are covered under Medicare Part B, and that are packaged in a single-dose container or single-use package.

Manufacturing 52

Manufacturing Utilities Government Provider 52

FDA Law

SEPTEMBER 20, 2021

From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law

DECEMBER 6, 2024

The draft guidance includes FAQs covering topics from across disciplines: regulatory review; chemistry, manufacturing, and controls (CMC); nonclinical and pharmacology/toxicology (PT); clinical; and clinical pharmacology. However, as we noted above, the CMC topics covered in this draft guidance will be covered in Part 2 of this blog coverage.

Clinic 59

Clinic Provider IT Electronics 59

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! With apologies to Rob Base and DJ EZ Rock , it took more than “two” to get this Emgality DTC TV commercial right (insert snare drum here please).

IT 40

IT Education Utilities Patient-Centered 40