News & Insights
A Valuable Research Tool
The FDA Purple Book Database: A Valuable Research Tool So, what exactly is the FDA Purple Book Database? First a few things it is not:a book purpleThe Purple Book Database is a list (downloadable or searchable on-line at https://purplebooksearch.fda.gov/ ) of all FDA approved biological products…
AstraZeneca’s Trial Is on Hold. It’s a Sign that the Science Is Working
Everyone awaiting a vaccine against Covid-19 must understand this fact: Bad outcomes may happen in vaccine trials. The good news is the U.S. Food and Drug Administration evaluates these outcomes before approving a vaccine. The purpose of clinical trials is to discover what can go wrong with a vaccine…
FDA Is Holding Virtual Panel Meetings for Medical Devices
Due to COVID-19, FDA/CDRH is beginning to hold virtual panel meetings for medical devices. On Sept 8-9, 2020, the Orthopaedic and Rehabilitation Devices Panel will meet to discuss the classification of several pre-amendment devices including: facet screws systems, semi-constrained toe (metatarsophalangeal)…