The FDA’s refusal to file letter surprised analysts. The note from the regulatory agency had to do with the date when the manufacturing site would be ready for inspection and a question about the submission of the drug master production record, Acorda said.
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.