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GlossaryFDA registration

process of listing products with the U.S. Food and Drug Administration

FDA registration refers to the process by which manufacturers and distributors of certain products, such as medical devices, pharmaceuticals, and food items, must register their facilities with the U.S. Food and Drug Administration (FDA). This registration allows the FDA to monitor and inspect these facilities to ensure compliance with safety and quality standards. It is important to note that FDA registration is not the same as FDA approval, which involves a more rigorous review process to evaluate the safety and efficacy of a product before it can be marketed.

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community Do People even realize that we got a new Treatment Option and Kintor Officially released Pyrilutamide?

in Treatment 56 upvotes 4 months ago

A new hair loss treatment, Pyrilutamide, has been released and is claimed to be a strong anti-androgen, potentially effective when used with finasteride. However, there are mixed opinions on its effectiveness and safety, with some users skeptical and others purchasing it.

community FDA approves Cassiopea's WINLEVI (CB-03-01, 1% formulation) for Acne

in Technology 34 upvotes 4 years ago

The conversation is about the FDA approval of WINLEVI for acne treatment and the anticipation of Breezula, a hair loss treatment using the same active ingredient, which may indicate a positive future for Breezula's release. There is disappointment that Breezula's results are not optimal, but it is seen as progress in hair loss treatment.

community Why are there no FDA approved NSAA's yet?

in Research/Science 6 months ago

The conversation discusses why there are no FDA-approved NSAAs like RU58841 on the market, despite their potential superiority to 5AR inhibitors like finasteride. It explores the effectiveness of treatments like Minoxidil, finasteride, and RU58841 for hair loss.

community If Ru58841 was an FDA approved medication and known to be safe would you recommend it before finasteride?

in Product 7 upvotes 11 months ago

The conversation discusses whether RU58841, if FDA approved and safe, would be recommended over finasteride for hair loss. Specific treatments mentioned include RU58841, finasteride, and minoxidil.

community Winlevi just got FDA approval, projected to be available early 2021 in the US

in Treatment 45 upvotes 4 years ago

The conversation is about creating a higher concentration of the newly FDA-approved hair loss treatment, Clascoterone (Winlevi), through compounding pharmacies and possibly organizing group purchases. Some users are unfamiliar with Winlevi and are asking for an explanation of the drug.

community Cassiopea Announces FDA Submission of New Drug Application for Clascoterone Cream 1%, the First New Mechanism of Action for Acne in Nearly 40 Years

in Technology 28 upvotes 5 years ago

The conversation is about a new acne treatment cream called Clascoterone Cream 1%, which is the first new mechanism of action for acne in nearly 40 years. One person joked about hoping their face will be as clean as their bald head after using the cream.

community How long until pyrilutamide or gt20029 get FDA approved?

in Research/Science 7 upvotes 1 year ago

Hair loss treatments pyrilutamide and GT20029 discussed. Pyrilutamide approval in 2 years, GT20029 in 5-6+ years.

community Dermatologist denied prescribing oral dutasteride because it’s not FDA approved BUT did prescribe ORAL minoxidil 😂

in Finasteride/Dutasteride 31 upvotes 4 months ago

A 22-year-old male has been using oral finasteride for a year with no improvement in hair loss and was denied dutasteride by a dermatologist due to FDA approval issues but was prescribed oral minoxidil instead. The user is seeking advice on whether to switch to dutasteride, continue finasteride, or add minoxidil.

community How much will GT20029 cost if it becomes FDA approved?

in Treatment 6 upvotes 6 months ago

The conversation is about the potential cost of GT20029 if FDA approved, with estimates around $150/month. Comparisons are made between GT20029, finasteride, and their mechanisms and side effects.

community will cb-03-01 price be cheaper if it FDA approval

in Treatment 2 upvotes 3 years ago

The conversation discusses the high prices of hair loss treatments, specifically cb-03-01 and KY19382. It also mentions the use of Minoxidil, finasteride, and RU58841.

community BREEZULA COVID UPDATE: Filing for Special Protocol Assessment with FDA

in Research/Science 64 upvotes 4 years ago

The conversation discusses the progress of Clascoterone (Breezula) for hair loss treatment, noting that COVID-19 delayed female trials by three months but Phase III trials for males are proceeding with a Special Protocol Assessment filed with the FDA. Users express hope for Breezula as an alternative to existing treatments like finasteride and minoxidil, despite concerns about its potential high cost.

community Kintor Pharmaceutical Announced U.S. FDA Has Greenlighted Phase II Clinical Trial for Pyrilutamide to Treat Androgenetic Alopecia

in Treatment 23 upvotes 3 years ago

Chinese company gets green light for Pyrilutamide Phase II trial for androgenetic alopecia. Androgen receptors downregulate in androgen deficient environments.

community Reddit’s amatorial meta analysis of 17 already avaliable hair loss prevention treatments that were found to be effective in clinical studies but are not FDA approved for MPB. PROS and CONS. (2022 Guide if Finasteride and Minoxidil are not working/ give you sides/are not enough) 77 studies linked!

in Research/Science 586 upvotes 2 years ago

The post and conversation are about hair loss treatments that have been found to be effective in studies. There are 19 different treatments mentioned, including oral minoxidil, oral dutasteride, topical finasteride, RU58841, and more. The best treatment for an individual depends on factors like availability, cost, side effects, and personal preferences.

community Why are more people not using RU58841

in Product 14 upvotes 7 months ago

People are not using RU58841 for hair loss because it's not FDA approved, lacks long-term safety data, and is difficult to obtain and verify. They prefer FDA-approved treatments like minoxidil, finasteride, ketoconazole shampoo, and microneedling.

community Will we be able to acquire pyrilutamide when it is on the market in China?

in Research/Science 9 upvotes 1 year ago

The conversation is about the possibility of obtaining Pyrilutamide, a hair loss treatment, once it becomes available in China, despite it not being approved by the US FDA yet. The user wants to use Pyrilutamide along with other treatments.

community HAIR REGENERATION HUMAN TRIALS with Verteporfin

in Research/Science 13 upvotes 2 years ago

A new human trial using an FDA-approved treatment for wound healing called Verteporfin, which may potentially be able to reverse scarring and regrow hair in that area. The trial is only lasting one month so far.

community Why does it seem everyone favors finasteride over dutasteride?

in Female 62 upvotes 6 months ago

The conversation discusses preferences for hair loss treatments, specifically finasteride over dutasteride. Users share personal experiences, cost considerations, FDA approval status, and potential side effects, with some switching between treatments to find what works best for them.

community Where have all the microneedle pens gone?

in Microneedling 15 upvotes 1 month ago

Microneedle pens for hair loss are harder to find on Amazon due to FDA regulations on needle length. Users suggest buying from AliExpress or Temu instead.

community Why is everyone not directly advised Dutasteride?

in Finasteride/Dutasteride 162 upvotes 1 month ago

Dutasteride is less commonly prescribed for hair loss because it is not FDA-approved for this purpose, unlike finasteride, which is more accessible and preferred due to fewer side effects. Dutasteride may be more effective in reducing DHT but has a longer half-life and potentially more significant side effects.

community Dr. Gabel Doesn't Use Verteporfin

in Transplants 3 upvotes 2 months ago

Dr. Gabel doesn't use Verteporfin because it's not FDA approved. The user is getting FUT and wants to minimize scarring and maximize hair regrowth.

community Are there any news about scube3? Did they want to start the clinical trials soon?

in Technology 7 upvotes 8 months ago

The conversation is about skepticism regarding new hair loss treatments until they are FDA approved. People have been joking about treatments being 5-7 years away for decades.

community Tressless When They See Verteporfin Results

in Transplants 181 upvotes 1 year ago

The conversation discusses the potential of Verteporfin, an FDA-approved drug, for hair loss treatment, particularly in combination with microneedling or PRP. Users express hope and curiosity about its application, while some remain cautious due to the need for more extensive testing.

community KX-826: What can I expect from the new launched cosmetic product?

in Research/Science 9 upvotes 3 months ago

The user is exploring KX-826 as a potential hair loss treatment due to intolerance to FDA-approved drugs like Minoxidil and finasteride. They seek fundamental help and information about KX-826.

community What would hair loss treatment be like in the 2030s?

in Treatment 5 upvotes 4 months ago

The conversation discusses future hair loss treatments, with mentions of dutasteride potentially gaining FDA approval and increased popularity. Skepticism remains about significant advancements due to limited funding and reliance on cosmetic companies.

community Recent Study finds Laser caps are more effective than 5% minoxidil for AGA

in Research/Science 124 upvotes 8 months ago

Laser caps are found to be more effective than 5% minoxidil for treating hair loss, and when combined with minoxidil, they are even more effective. Some users report positive results with laser treatments, while others see no change; the devices are FDA approved, but opinions on their efficacy vary.

community Verteporfin (Visudyne) group buy 🌷

in Treatment 28 upvotes 2 years ago

User seeks participants for Verteporfin group buy. Verteporfin, FDA approved, may regenerate hair follicles and sweat glands through heavy microneedling.

community So we’re just ok with taking a research chemical now?

in Treatment 181 upvotes 3 years ago

The conversation discusses the use of RU58841, a non-FDA approved research chemical for hair loss, with mixed opinions on its safety and effectiveness. Some users are willing to try it as a last resort after other treatments like Minoxidil and Finasteride failed, while others express concerns about potential long-term side effects and lack of official research.

community "Nah bro, I don't need finasteride! I'll just use saw palmetto and rosemary oil!"

in Satire 315 upvotes 1 month ago

People often turn to natural remedies like saw palmetto and rosemary oil for hair loss, but these are not as effective as FDA-approved treatments like finasteride and minoxidil. Some users express concerns about potential side effects of finasteride, while others share positive experiences with it.

community This subreddit is 250K members strong, and only 95 likes for this game-changing Verteporfin research? It's pitiful. We need to be encouraging and supportive to any hair transplant surgeon willing to do research on Verteporfin! Go like the video, leave an encouraging comment, and spread this video

in Research/Science 108 upvotes 4 months ago

The conversation discusses the need for more support and awareness for Verteporfin research in hair loss treatment, emphasizing its potential benefits and quick implementation due to existing FDA approval. Users express skepticism due to past scams but acknowledge the importance of encouraging doctors to conduct trials.

community 7 months on just topical finasteride (caretopic)

in Progress Pictures 52 upvotes 5 months ago

A user shared their 7-month progress using only topical finasteride for hair loss. They recently started a new, non-FDA treatment and will evaluate its effectiveness in 6 months.