In a first for the agency, the FDA has developed and tested a consumer-friendly Drug Facts label to support the development of an over-the-counter version of naloxone, an emergency opioid overdose treatment.
A DFL is required for OTC drug products and the FDA has never before proactively developed and tested one. But in this case, the agency wanted to create “model labeling that sponsors can use to obtain approval for OTC naloxone and increase its access,” according to FDA chief Dr. Scott Gottlieb.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.