Health insurance isn’t all about payments. The Food and Drug Administration has a lot going for it this year as well.
- Here are some standout areas to focus on:
1) Transition from Pandemic Operations: FDA is Confirm guidance Handling products with Emergency Use Authorizations during the COVID-19 public health emergency.
- Agencies want ‘manufacturers who are compliant and committed to being in the market for the long term’ [to] John Fuson, a partner at law firm Crowell & Moring and a former FDA staff member, said:
- Remember: EUA does not rely on public health emergency designations and does not disappear when an administrator terminates your status.
2) Supervision of diagnostic tests: of valid act James Boiani, a partner at the law firm Epstein Becker-Green, said the FDA could try to increase its own oversight of lab-developed tests, although it wasn’t included in the recent omnibus. Stated.
- FDA proposed a framework Because of this in 2014.
- Legal action is likely if the agency moves back to supervising lab tests, Boiani added. [FDA]”Especially now, given the history of Congress’ work to give the FDA explicit powers and consider not doing it,” he said.
3) Artificial Intelligence: FDA lawyers also question whether the agency will proceed with final guidance on how to process premarket submissions for medical products that use AI.
- Bradley Thompson, FDA attorney for Epstein Becker Green, said: “One of the things that makes it difficult to regulate artificial intelligence is that it’s constantly learning from its behavior. The FDA’s model is: I didn’t really explain it.”