article thumbnail

The Future Of Vision And Eye Care

The Medical Futurist

Treating less serious ailments gets faster, more targeted and more efficient, while the means for curing more serious and life-altering illnesses improve. Their research showed promising results for lab rats, and they plan to carry out the first human trials in the second half of 2017 and gather preliminary results during 2018.

Diabetes 105
article thumbnail

Second Circuit Agrees that Copay Assistance Programs May Violate the Anti-Kickback Statute

FDA Law

Pfizer manufactures tafamidis, a breakthrough treatment for a rare, progressive heart condition known as transthyretin amyloid cardiomyopathy. Most of these cases have settled out of court (see, for example, Actelion Pharmaceuticals , 2018; Astellas Pharma and Amgen , 2019; Gilead Sciences , 2020). Background.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

FDA Publishes De Novo Classification Final Rule with Few Changes from the Proposed Rule

FDA Law

The regulatory uncertainty has ill?befitted It was published approximately three years after the December 7, 2018 release of the proposed rule (see blog post on the proposed rule here ). In the PMA context, the statute permits FDA to withhold approval if manufacturing facilities do not conform to QSR requirements. Part 860.

article thumbnail

Advance Care Planning Discussion: Susan Hickman, Sean Morrison, Rebecca Sudore, and Bob Arnold

GeriPal

Then listen to these prior podcasts with Sean Morrison and Rebecca Sudore about this issue, and we recently discussed differences between Advance Care Planning and Serious Illness Communication with Juliet Jacobsen and Rachelle Bernacki. . 2018 Systematic Review of Systematic Reviews on ACP. Where does POLST fit in with this debate?

Illness 72