FDA to Sunset Alternative Summary Reporting (ASR) Program
The FDA has announced an end to the alternative summary reporting (ASR) program [...]
18
06, 2019
30
05, 2019
Postmarket Surveillance is Most Effective when Approached as an Enterprise Interest
FDA regulation 21 part 822 lays out the process, the rules, and the products tha [...]
20
03, 2019
What to Make of FDA’s Secret Cache of Device Adverse Events
Last week an investigative report revealed the FDA has millions of “hidden” seri [...]
