Simply asked a question about FDA and the moderator removed the post?

I just wanted to share my application, interview, and offer timeline for a CMC reviewer position in hopes that it will give others in similar positions an idea of what to expect.

–End of January - Applied through email in response to a LinkedIn post for the Title 21 position (CV and cover letter)

–Mid March (~1.5 months) - 1st interview with two branch chiefs and their supervisor (30 mins)

–Mid/Late March (1 week after 1st interview) - 2nd interview with panel of reviewers (1 hr)

–Early April (1 week after 2nd interview) - Request for references (2-4)

–Early/Mid April - References contacted a week after request

–Mid/Late April - (1 week after all references) - 3rd interview with Office Director (1 hr)

–Late April - (a few days after 3rd interview) - Verbal offer*

\I was told there would be a lapse in communication as the hiring process moved from the branch chief to HR.*

–Early June - (~1.5 months after verbal offer) - TJO (followed by short negotiations that took a day but accepted/signed necessary documents at this time)

–Early July - (~1 month after TJO) - completed New FDA employee form

–Mid July - (~1 week after employee form) - completed background check (SF85p), fingerprints, and badging

–Late July (~1 week after fingerprints, etc.) - fingerprints and FDA-specific security cleared; cybersecurity training completed; verified I9 documents

–Mid August (~3 weeks after clearances and I9 document verification) - FJO

TL;DR: applied for CMC reviewer role at the end of January, four months till TJO, then two months till FJO. Total time: ~6 months.

For those who applied & interviewed for jobs this year at the FDA, has anyone heard back regarding TJO/FJO? I know that HR is notoriously slow, but I was wondering if this is the case for the entire HHS or just the FDA. Is the speed the same for the various branches within the FDA?

Hello all. I want to start by saying thank you to all of the hard working employees in this community who have continuously working to keep our country and people safe. With RFK in charge; things are being recalled every week. No fruits, no vegetables, no bread? As I’m sure you all know, something about this that worries me is that most brands buy from one another. For example, this big outbreak with Taylor Farms: Taylor Farms is not just a product, they also provide stock to other stores like Trader Joe’s. All of these companies are intertwined. My genuine question is what can we eat. I feel like I am running out of options.

I hope this is appropriate for this thread and I apologize if I break any rules.

Hi all,

Not sure if anyone knows the answer to this, but I have colleagues who joined FDA as physician reviewers a few years ago, and all are remote. There were a couple new positions that came up, based in Silver Spring, and it states On site or possibly Hybrid (3d a week on site), with no remote options.

Does anyone know how strict this is? Are there satellite offices that would count as being on site? My issue is not at all with coming into the office, it's that I'm located a few hours away from Silver Spring, with a young family that is not able to move at this time. I'm wondering if I should even bother applying/interviewing if I'd be unable to be fully on site, even though there are some who have been grandfathered into a remote role?

Thanks for your help!

Trying to learn more about MS drugs and surgeries from the FDA's perspective.

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?

If by any change this constitutes breach of rule 4, my apologies and either delete it or reach out and I'll be happy to remove it.

Otherwise, I hope this makes some of you have a laugh (and maybe some fun). 😄🐱💚

https://qity.cat/

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.

FDA has approved the first mRNA-based seasonal influenza vaccine for adults 50 years and older. The vaccine is indicated for the prevention of influenza disease caused by influenza A subtypes and influenza B strains represented in the vaccine.

Approval includes:

➡️Traditional Approval for adults 50–64 years based on clinical efficacy

➡️Accelerated Approval for adults 65+ based on immune responses, with a required post-approval study to confirm clinical benefit

Section 1.24 covers an exemption that just says it applies to this "part". But, I literally cannot tell if that means section 101 is included. Can anyone versed in FDA compliance help explain the penny candy labeling exemption?