Ad Law Tool Kit Show – Episode 1 – Product Safety and Recalls
Foreign device manufacturers should anticipate greater chance of FDA inspection under new FDA leadership
Over 400,000 COVID-19 rapid test kits have been recalled by Australian manufacturer Ellume. The reason? Way too many false positive results. “At Ellume, we understand that trust is central to fulfilling our purpose...more
A comprehensive guide to the latest developments affecting non-prescription drug products under Monograph Reform. American Conference Institute’s Advanced Legal, Regulatory and Compliance Forum on Over-the-Counter Drugs will...more
ACI’s FDA Boot Camp returns in a completely interactive virtual format to help life sciences attorneys and executives to master the fundamentals of FDA Regulation... Gain essential working knowledge of core FDA concepts,...more
Navigating FDA’s regulatory enforcement strategies is paramount to successfully marketing health and medical products for COVID‑19—especially since the pandemic has dominated FDA’s enforcement activity this year....more
Food - FDA Released Final Rule on Gluten-Free Labeling – The final rule establishes compliance requirements for fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients, that use the...more
In 2020, even the hand sanitizer is potentially suspect. Retailers, distributors and corporate purchasers are now grappling with the added problem of clearing their shelves of it and stopping employees from using the Food and...more
Welcome to 2020's second edition of Product Lines, our e-newsletter that focuses on toxic torts and product liability issues. For this edition, we are reporting on several important and timely legal issues. As you will...more
The Editors' Note - Welcome to the third issue of Decoded, Spilman's e-newsletter focusing on technology law, including data security, privacy standards, financing technologies, and digital-based means of conducting...more
FDA Plans to Restart On-Site Inspections the Week of July 20 -Commissioner Hahn announced the goal of restarting inspections, which were halted due to COVID-19. The FDA has developed a COVID-19 Advisory Rating system to...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug practice....more