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 [...]
16
12, 2016
Risk Management + Adverse Event Reporting: FDA Guidance
Risk management and adverse event reporting protocols for medical device manufac [...]
