FDA Law

AUGUST 4, 2022

Pfizer manufactures tafamidis, a breakthrough treatment for a rare, progressive heart condition known as transthyretin amyloid cardiomyopathy. Further, “there is little utility in comparing the language of the BIS to that of the AKS.”. Background. Pfizer set the price of tafamidis at $225,000 for each one-year course of treatment.

Manufacturing 98

Manufacturing Medical Government IT 98

FDA Law

DECEMBER 16, 2024

The final guidance appears not to make any meaningful changes that are actually likely to support or incentivize its increased utilization, which is disappointing, although not unsurprising. We noted in last years post that in Fiscal Years 2018 2022 , fewer than 100 510(k)s went through the Third Party Review Program annually.

Consulting 52

Consulting Manufacturing Utilities Provider 52

FDA Law

SEPTEMBER 11, 2023

More recently, in 2019, FDA announced a push for predicate modernization ( link ) following a 2018 plan to modernize the 510(k) program by eliminating use of old predicates, sunsetting older predicates, and establishing the Safety and Performance Based Pathway ( link ).

Medical 64

Medical Electronics Manufacturing Utilities 64

FDA Law

JUNE 16, 2023

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers. We address each below. Best price?

Manufacturing 45

Manufacturing Provider Consulting IT 45

FDA Law

DECEMBER 11, 2023

This is based on FDA’s reported 2018 review of the CLIA database. [2] This is 50% greater than the 2018 numbers relied upon by FDA in its estimates. [3] Unless FDA provides timely responses to pre-submissions, laboratories (and current IVD manufacturers) will not be able to submit applications that address FDA’s expectations.

IT 69

IT Medical Patient-Centered Provider 69

FDA Law

FEBRUARY 28, 2022

The Guidance provides practical advice for device manufacturers to utilize patient engagement in clinical studies.

Patients 52

Patients Clinic Medical Patient-Centered 52

FDA Law

SEPTEMBER 20, 2021

First, CDER will publish a new MAPP (the Manual for Policies and Procedures, meant to guide CDER staff in their review activities and interactions with sponsors) describing: (1) early engagement with sponsors and (2) “science- and risk-based approaches” for CMC development that “may be warranted and utilized.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52