Cassandra Rasmussen

King & Spalding

+ Follow Contact

Latest Posts › Medical Devices

Share:

A Magic Mixing Cauldron for the 21st Century: FDA’s new guidances on using real-world data in regulatory decision-making

In December 2016, fifteen Food and Drug Administration (FDA) officials, including then-Commissioner Robert Califf and current Acting Commissioner Janet Woodcock, published an article in the New England Journal of Medicine...more

11/10/2021 / 21st Century Cures Act , Data Collection , Drug Approvals , EHR , Food and Drug Administration (FDA) , Medical Devices , New Guidance , Pharmaceutical Industry , Prescription Drugs , Real World Evidence

France – Thresholds for Prior Authorization of Agreements with Healthcare Professionals and for Benefits of Low Value are Finally...

The two arrêtés [orders] setting thresholds for transfers of value from pharmaceutical and medical devices companies to healthcare professionals, institutions, and other actors of the healthcare sectors (Healthcare...more

8/25/2020 / France , Healthcare Workers , Medical Devices , Notification Requirements , Pharmaceutical Industry , Prior Authorization

France - New notification and authorization regime for exemptions from benefits/payments to the healthcare sector will enter into...

In France, Ordinance No 2017-49 of 19 January 2017 significantly modified the rules governing payments from life sciences companies to the healthcare sector. After more than three years, on June 15, 2020, Decree No 2020-730...more

6/30/2020 / Essential Health Benefits , France , Healthcare , Medical Devices , Notifications , Pharmaceutical Industry , Provider Payments

3 Results

View per page

Page: of 1