r/FDA

I’ve accepted a TJO at FDA for a reviewer position, and have confirmed a September start date with my onboarding specialist. However, I was notified that FJO letters are delayed and that even August 24th FJO letters were still pending approval two weeks ago.

Any updates on whether any September hires have gotten their FJOs or an expected timeline? The only thing I know is that there is a huge wait/backlog due to the large number of new hires expected to join.

AI can already review regulatory documents, labels, complaints, and compliance data. But can it replace Regulatory Affairs professionals?

Regulatory work is more than document review—it requires strategy, judgment, risk assessment, and communication with regulators.

Will AI replace Regulatory Affairs, or will regulatory professionals who use AI replace those who don’t?

What skills should RA professionals focus on to stay ahead?

#RegulatoryAffairs #AI #FDA #MedTech #LifeSciences

Question for others who have gone through the hiring process at FDA in the last year. What has been the wait time between providing references and reveiving verbal offer and TJO?

Applied: 3/10/26

Completed 2nd round of interview(s): 7/27/26

References requested and sent: 8/3/26

Any insight would be much appreciated!

Got a Team Leader who is pretty much a bully, making my life miserable. Now that the Union is gone, is it still possible to file a grievance, and if so, how? Or is the only option essentially to find a new job?

Hypothetically speaking:

Say you have a series of psychoactive products sold by a series of companies. These products are highly variable in formulation legal, pseudo-legal non-GRAS, or controlled substances which can be eaten as a candy/baked good, drank, or used in a capsule like in a dietary supplement, or can be also be smoked or vaped.

In this hypothetical scenario, pretend you found and later confirmed alterations to laboratory testing reports for products sold online on a very large scale.

Which FDA entity would have the broadest jurisdiction here and would that jurisdiction cross into the FTC or DEA?

I heard that FDA staff & CDER officials were really unhappy with the recent PCAC meeting where the AdCom voted Yes on most of the peptides in 2 meetings. Anyone hearing more about this? FDA staff at the meetings said their analyses weighed against compounding of the peptides (and they were right) but the panel voted yes on all but one anyway.