[WEBINAR] Update on the California Environmental Quality Act: What’s New for 2018
CorpCast Episode 1: Sections, 204, 205 and In re Numoda
As 2021 comes to a close, Big Molecule Watch reviews the top five biosimilar regulatory developments of the year... President Biden Signs Orange Book Transparency Act - In January, we reported that President Biden...more
On September 20, 2021, the FDA issued a revised final guidance for industry entitled “Questions and Answers on Biosimilar Development and the BPCI Act” and a third revision to its draft guidance entitled “New and Revised...more
An Emergency Use Authorization (EUA) is a mechanism used to enable the accessibility and use of medical countermeasures, including vaccines, during public health emergencies. Under an EUA, FDA may allow the use of unapproved...more
The FDA has issued warning letters to manufacturers of products marketed as medical foods to treat a range of medical conditions, including fibromyalgia, autoimmune disorders, irritable bowel syndrome, arthritis, asthma,...more
FDA Warning Letters Provide Opportunity for Food-Safety Reminders During Viral and Bacterial Outbreaks - The U.S. Food and Drug Administration (FDA) sent warning letters to Jimmy John’s Franchise, LLC and its supplier...more