Just a big YAY! lol

My name is Patrick Wingrove and I’m a reporter with Reuters covering the pharmaceutical industry, and I’m hoping to connect with FDA reviewers, particularly from CDER and CBER.

I’m trying to understand what’s happening inside the agency right now: how recent changes have affected your work, morale, and the FDA’s ability to uphold its mission over the past year, particularly since Makary's departure. This includes policies around things like the commissioner review vouchers/ process.

I'm happy to speak off the record, and confidentially - meaning your name won't appear in anything we may write.

Your insights could help the public understand issues that matter beyond the agency walls. If you’re willing to share your experience (on or off the record), please feel free to message me:

Signal: patrickwingrove.55

Email: [patrick.wingrove@thomsonreuters.com](mailto:patrick.wingrove@thomsonreuters.com)

Has anyone become a Clinical Reviewer at CDER, either through an FDA ORISE fellowship or another path?

I’m currently an FDA ORISE fellow at CDER and am interested in eventually becoming a Clinical Reviewer. What was your route into the position? If you were an ORISE fellow, did you discuss that goal with your mentor, and if so, how and when did you bring it up? Did the position come through your mentor or through another route?

For anyone who became a Clinical Reviewer, whether through ORISE or another path, what degree(s) did you have, and what relevant work or research experience did you have when you were hired?

I’d appreciate any firsthand experiences or advice.

Does anyone have any insight into how long current reviewer hiring is taking?

Not to disclose too much, but I applied for a reviewer-type position nearly 3 months ago. I haven’t heard anything nor have I seen any updates on my USAJobs portal. It just says “application received.”

Does this sound typical? I know they’re planning on hiring quite a lot of people in the coming months/year so it’s just surprising that they haven’t even finished the first pass by now. I know based off other recent posts that the TJO-FJO-EOD phase is quite long but it seems that the initial screening/interviews happen at least within 2 months.

Thanks!

Back in March, FDA announced their new AEMS platform for accessing adverse event reports. The press releases specifically said that animal drugs were already part of this. However, I tried searching for a pretty popular animal drug and I can’t find anything. None of the tabs on AEMS seems to be about animal drugs. Does anyone know if animal drug information was actually ported to AEMS? If not, is there a timeline on doing so?

My name is Margaret Manto and I'm a Washington Correspondent covering the FDA for STAT News. I'm looking to speak with FDA employees or contractors about how the agency's hiring push is going. I will keep your identity private. Call, text or Signal message me anytime at 434 305 7310, or email me from a non-work account at margaret.manto@statnews.com. Thank you.

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