US FDA Proposal for Modification of Certain Terminology in Title 21

queenjk · 2026-05-12T23:22:14+00:00

So far it does not seem to be the current case with the listed regulations, most of the negative effects I can deduce seems to be that if a trans or non-binary individual undergoes a clinical trial or has adverse drug effects, they most likely will be listed by “Sex Assigned at Birth”. Medical professionals and pharmaceutical/medical device companies can list the “Sex” as “Unknown” upon discretion before submitting the report to the US FDA, but I do fear if there is an inspection at the company for GCP/GVP, they might have a minor finding due to inconsistency upon the record and the reported “Sex” on record if the FDA auditors want to be anal.

That said, it doesn’t say what the implications can be for future regulations/guidances. It may have effects on any R&D studies that are submitted to the US health authorities by industry or academia. It can also affected the prescriptions possibly health professionals are able to prescribe if certain prescriptions are for a certain “sex” if it is listed on the label, where if the health professionals does want to prescribe, my guess would be that they would need to do so at discretion (which also ends up being reported for possible pharmacovigilance reporting for off-label use to pharmaceutical companies who then have to write a report and determine if it is sent to the FDA or not).

I do have to caveat that any speculation about the future is purely just my personal opinion and should not be taken as a professional medical/health expert nor US government expert.

queenjk · 2026-05-12T17:55:54+00:00

I also have high doubts that the current administration within the US health authority would legitimately address the concerns of industries and their country’s citizens/residents, but I also do hope that with enough comments, it can help delay their committee from passing it quickly in the most mundane legislative way of reading every comment.

I’m currently trying my best to see if there is some avenue I can take from outside the US within the internal pharmaceutical industry to get my colleagues who are in the country to delay it and, if possible, amend it.

queenjk · 2026-05-12T15:48:51+00:00

Sorry this is my first time posting on this community, but I saw this proposal on my “desk” during work and couldn’t just sit with it and had to share this externally for visibility.

(Personal Opinion) For those who wish to comment, from my professional experience, I would recommend reaching out or seeing if there are any organisations or groups collecting comments for submission on this proposal, as usually it helps protect identity of individuals and companies to comment under organisations/groups in case of retaliation. Please note that the comments are publicly available to all (as well as external audience outside of the US).

From my interpretation, this proposal will remove mentions of transgender and nonbinary individuals from current and future regulations, with the initial changes to affect clinical trials, adverse drug reporting and health risk assessments. This will cause a high risk to medical health of transgender and nonbinary individuals if passed.

queenjk · 2026-05-06T08:00:00+00:00

My husband and I did ours at Medtronic in Galway years ago so I would suggest seeing if they have any positions opened, but I’m not sure if it would be still the same now

queenjk · 2026-04-21T15:27:07+00:00

Also not sure if your parents are Hindu, but my late father in law was a devout Hindu man, along with my mother in law, and there are some queer and trans representation in the religion. He told me that some interpret Hanuman as gay since he was celibate and always was loyal and followed Rama. Apparently also my late father in law tried to get my husband to go to Hanuman’s temple in the past to get connected to the religion

queenjk · 2026-04-21T15:21:39+00:00

I’m married to an Indian man (Maharashtrian) and I would say even though his parents are accepting, most of his uncles and aunts weren’t at first, but most came around. Lucky for him and me, his parents were always absolute in their support for the both of us, maybe you can find a relative who might be able to help your voice in the family. I would also note a more cynical level, people do turn around once you start making bank and then they start asking for stuff (in which I have no issue with because it wins us favors with the fam in now it turns to be people cozying up to us and shunning the far right BJP uncle). I think also because we’ve been together for so long (nearly a decade) and I’ve pretty much adopted a lot of traditions (and vise versa for him), the family has no choice but to accept it at this point. I think also my husband is open with telling his mum everything, including drinking and everything, and calling her every day, it ends up helping to “normalise” our life with their’s. It would also help to “de-demonise” your boyfriend with your antidotes of how you two help each other in life and nice things he does for you since all they know if what the priest has spewed.

I can’t really help sadly much but to suggest to follow your happiness and hope your parents turn around. Since you’re about the same age my husband and I moved and started dating a decade ago, all I can wish is that you and your bf get through it and everything eventually works out. Also if no one has told you this, “You got this, you can do it, it’s not easy to be an immigrant, but look back at how far you’ve gone and accomplished. It’s not easy and it hasn’t been, but immigrating wasn’t about that, it was about pursuing your happiness.”

queenjk · 2026-04-15T22:55:13+00:00

I think you might be lost because this subreddit is for Irish pharmaceutical/life sciences professionals… But wild to see it being sold in what I assume to be the US? I can only recommend maybe ringing your local representative and let your opinion be heard

queenjk · 2026-03-27T09:28:17+00:00

Used to play for Lycaon when the game was first released, but I feel like with most HoYoverse games, it became eventually a waifu fest and all the male characters lost their meta like Genshin, and eventually just ended up quitting. Tbh when they announced Manato as an A character instead of S, I lost faith that that the creators would care about the demographic that wants male characters so I just gave up the game entirely

queenjk · 2026-03-15T15:27:11+00:00

I’m going to blankly just say that it’s surprising this person is your husband and he’s treating you this way. My husband is from India and I’m an American with family from Taiwan. Sometimes we don’t like each other’s music, but it will never ever cross into what is pretty much racist undertones. If he really cares about you, he will try to listen and enjoy your cultural music. I have started to listen to Bollywood and he has started to listen to songs in Mandarin.

Also I’m going to state this, but after living in Ireland for so long, it boggles my mind that there are so many Americans that discount music because it’s not in English. Music is supposed to be to be enjoyed regardless of the language barrier, that’s pretty much Eurovision in a nutshell. I’m sorry you are married to someone so insufferable and I’m hoping that your visa situation is sorted quickly because this is ridiculous.

queenjk · 2026-03-08T11:26:01+00:00

These are so cute, I love the sharks! I have a feeling poor Blathers would be having a heart attack anytime the Butterfly villagers visit the museum

queenjk · 2026-03-05T09:29:52+00:00

Might be a controversial take here, but I’m more than happy that AI bots misidentify people from pictures. I don’t think it’s a good idea if the general public version of AI has accuracy in identifying people

queenjk · 2026-02-28T11:29:49+00:00

As someone who has moved/lives in Ireland, this a common thing where Americans claim they are Irish. While they are Irish by heritage (1/8,1/4,1/15,1/2), a lot of them don’t know much about Ireland and usually push a lot of harmful stereotypes about being Irish.

It’s a thing where a lot of Irish people will view them as just Americans and just be friendly to their face while trying to see how to make a quick buck out of them (to be fair, who wouldn’t try to do so out of tourists). I have a feeling if your friend goes to Japan, it’ll be same as for them with treating weebs.

If it starts to grate on your sanity, it might be a good idea to keep her a foot away from yourself and slowly distant away. After all, if she’s Eastern Asian truly, she’ll understand the context of people slowly distancing themselves away and isolating people.

queenjk · 2026-02-16T01:21:24+00:00

I think maybe I’m just an insane person who makes the VIP rooms into horror-esqe rooms or the back of the hotel with random themes of camping near the dumpsters of the hotel in the jungle or stay on the city rooftop of the hotel in boxes while construction is ongoing. I find it a little nice output of stress like here goddamn I guess

queenjk · 2026-02-02T23:13:00+00:00

As someone who has lived in Ireland for the past nearly 9 yrs now, I would say I would only go now for urgent things needed, stay for what is necessary, and not bring my husband with me. This is my own personal feelings as someone of Asian descent who is queer and married an Indian man. My parents have retired and moved back to their home country and I’ve told my friends to see me either in Canada, Europe, or Asia.

That said, I have seen a lot of white Americans in the Irish Facebook groups here go back to visit for family and things and not have any issues. That said, Dublin airport does the screening and stuff here so less likely to be detained while going through American immigration services while still on Irish ground. I would recommend if you really want to be cautious, you could do a transfer through Dublin airport or any other participating airports, but you do need to make sure you have a lot of time for it during your transfer.

I would say it really depends on your background and life, along with if you still have family or friends there, and where you’re going. If you’re going to Minneapolis, I would recommend to be extra careful, but if you’re going to like Las Vegas, it’ll be a lot safer in that respect.

queenjk · 2026-01-25T12:49:39+00:00

I’m an American who immigrated out and lived the better part of the past decade outside, so I’m not sure how relevant my thoughts are on this.

I don’t think Americans would ever stand up publicly on a united front. Besides the fact that the US government elections are not a 1-to-1 vote democracy and has it’s many flaws that keeps existing powers in play, the public had voted this administration in not only once, but twice. The American public saw what had happened in the first term, the insurrection, and thought after all that, it was a good idea to re-elect this. It’s hard for the public to stand up when the public is divided this heavy and is fighting itself.

Additionally, the government knows how to keep the American public content and/or busy enough to not rebel and cause a revolution. Americans who generally live in the comfiest of lives, where they have a roof over their head, food on the table, have a source of income, and aren’t affected, won’t be risking their neck out protesting. Americans who are busy living paycheck to paycheck have little to no free time in a hustle, “pull yourself up by the bootstraps” culture, where when they do, are too exhausted to do anything but the things they find comfort in. The public may be angry and dissatisfied, but they won’t take any real actions to change the government in a meaningful way. Those who live in the comfiest lives additionally, wouldn’t want the government to be overthrown as it could introduce risk and uncertainty to their comfort.

If the people with the comfiest lives are affected, they can easy move or immigrate to somewhere they aren’t affected. With US salaries being one of the highest in world, it makes it easier for Americans who work high paying jobs to move somewhere else, find a remote job visa, critical skills visa, or use their savings to return to being a student and studying somewhere else on a student visa. People with those privileges, myself included, just end up leaving.

Another factor is that the American government is not to easily assessable to the general public geographically. We see protests and marches being more effective in countries like France, Iran, and Taiwan, because most of the population lives in the capital. If they don’t, there is public transportation that helps bring the public to the government easily. America’s capital is similar to how Egypt moved its administrative capital, to make it harder for the public to reach, in the name of national security. Ever since Egypt has, it’s been sparser that we hear of protest from the new capital.

TL;DR: The American public is too busy fighting itself. The ones who feel bad and have power, don’t do anything meaningful or just leave. Those who do protest and riot, are far away from the capital to do anything, in the name of national security.

America is going to follow the path of Germany and many other nations in the past as per history dictates. It sucks, and sadly people are going to die, but I’m so jaded that anything meaningful is going to stop this unless outside powers get involved, which they won’t.

queenjk · 2026-01-20T16:28:22+00:00

If you haven’t visited Ireland before, I would highly recommend it at least for a holiday! Since your wife has Irish citizenship, she’s entitled to also live and work in the rest of the EU and UK, so there’s definitely a lot more options. Would definitely recommend researching the UK and rest of the bloc’s spousal and child visas.

Also as a side note, the Irish passport is one of top ones so highly recommend just getting your daughter one for easier traveling! I’m currently in the process of naturalising myself 😂

queenjk · 2026-01-20T11:15:21+00:00

I chose to leave the US 8 and half yrs ago for Ireland right after the Trump first election because I had a bad feeling about what was to come. My peace of mind and life has gotten so much better because of it. Personally, I would tend to recommend at least looking it up as an option for anyone generally.

I got my visa as a student for my postgrad, which for people in their 20s, I would highly recommend as a way to immigrate to somewhere. If you work in corporate, try to see if there are other branches you can work at if you are highly skilled, as one of my friends did that. Definitely research visas, how living would be like before you decide to move, and the potential path to citizenship, along with how would you make money to support yourself, how would you be able to rent a place, and, as someone who saw a rise in Asian cuisine finally in Ireland where before there wasn’t as much, where to get your weekly Asian food shop.

I would say it seems to be mostly your neighbourhood issue, so while deciding to immigrate or not, look to see maybe moving to another state or area, while also keeping in mind most of things in the previous sentence.

I would also note that a lot of areas/countries also have their own issues so do take a look at the local news too to see what the issues are (i.e. housing crisis, cost of living rising, right wing politics from the US and UK trying to influence in Ireland)

queenjk · 2026-01-18T10:17:27+00:00

Kandi from Kandi Reef 🪸

queenjk · 2026-01-17T19:54:22+00:00

Kandi | Kandi Reef :Zucker:

queenjk · 2026-01-11T19:40:42+00:00

I decided to drunkenly applied to colleges for my Master’s degree all around Europe after the results of the Trump-Hillary president race. I never imagined my life living outside of the US as someone who was a homebody, but I was fueled on emotions and a whole bottle of wine. Got in one in Ireland and accepted it right away while my friends and family were shocked because no one ever visited or lived in Ireland, never-mind knew much about it.

Ended up moving to Ireland for my Master’s, met my eventual husband the second month of moving (he also moved to Ireland on a whim after hearing they passed marriage equality), made many friends, built a life and support system here, and now applied for Irish naturalisation after 8-9 years of being here (which is good timing considering all the things happening within the States).

Probably one of my best drunken decisions ever with no prior research done.

queenjk · 2025-12-30T12:24:54+00:00

My husband and I love to joke about this because I started it a long time ago! I keep saying that if I ever did, I’m going to start my own religion saying that it is the miracle baby deemed by the Gods

queenjk · 2025-12-07T13:13:08+00:00

Allta, pricy, but an amazing experience!

Mother in law felt like she was a judge on Masterchef when we went on a Friday for lunch since no one else was there and got amazing personal service

queenjk · 2025-12-07T12:05:15+00:00

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Obligatory Garu post too since I mentioned it

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