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

SEPTEMBER 11, 2023

The electronic Submission Template and Resource (eSTAR) program, which we blogged about here and here , also makes the highlight reel given its aim to improve consistency and efficiency in how 510(k)s are prepared. Over the years, we’ve blogged on similar initiatives related to the 510(k) pathway.

Medical 64

Medical Electronics Manufacturing Utilities 64

FDA Law

DECEMBER 12, 2023

In fact, clinical studies estimate that as many as 23% of cats suffer from urolithiasis. 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.)

Utilities 59

Utilities Manufacturing Provider Individual 59

FDA Law

DECEMBER 16, 2024

We previously discussed the Third Party Review Program in a blog post last year when FDA mentioned its expansion as part of its plan to address the resource gap for review of laboratory developed tests (LDTs) under the LDT final rule. As we have previously discussed, the Third Party 510(k) Review Program is not widely used.

Consulting 52

Consulting Manufacturing Utilities 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The draft guidance includes FAQs covering topics from across disciplines: regulatory review; chemistry, manufacturing, and controls (CMC); nonclinical and pharmacology/toxicology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. Section #3: Human Trials Finally, the guidance provides a quick overview of clinical study recommendations.

Clinic 59

Clinic Provider IT Electronics 59

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. The sponsor then gets the review ball rolling by submitting all of the efficacy supplement minus the final clinical study reports and clinical summaries.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law

AUGUST 3, 2022

3, 1992) (“It has come to the attention of FDA that laboratories have been manufacturing, “home brew” products, either from products already on the market, or from components, and utilizing these unapproved products for diagnostic purposes. These efforts have faltered and failed.

Lab Testing 98

Lab Testing Government IT Manufacturing 98