Search

for
Search:

GlossaryFDA approval (FDA clearance)

process ensuring a product's safety and effectiveness for public use

FDA approval is the process by which the U.S. Food and Drug Administration (FDA) formally evaluates and authorizes a product, such as a medication or medical device, for public use based on evidence of its safety, efficacy, and quality. This rigorous process involves multiple phases of clinical trials and extensive review of data to ensure that the benefits of the product outweigh any potential risks.

Related Terms

Sort by

Community Join

30 / 692 results

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 Developing a Cheap Low-Level Laser Therapy Device for Hair Loss

in Technology 6 upvotes 1 year ago

Low-level laser therapy (LLLT) stimulates hair growth but current devices are expensive. A proposed non-profit project aims to create affordable, 3D-printed LLLT devices and collect data on their effectiveness.

community HMI-115 question about potential earliest access

in Research/Science 8 upvotes 1 year ago

Hair loss treatments discussed include Minoxidil, Finasteride, and RU58841. HMI-115, a monoclonal antibody drug, is in phase 1 and 2 trials for different conditions, but its availability on the gray market is unlikely due to high production costs.

community HMI 115 Phase 1 update: Changes to clinicaltrials.gov page

in Research/Science 25 upvotes 1 year ago

A Phase 1 update for the HMI 115 clinical trial, which involves 16 participants and is expected to end in July 2023; as well as changes to the recruitment process, including treatment protocols with Minoxidil, Finasteride, and RU58841.

community U/joaopassos444 , HATS OFF brother !!

in Research/Science 125 upvotes 3 years ago

A new hair loss treatment theory beyond minoxidil and finasteride is proposed, causing mixed reactions in the community, with some members eager to explore and support it, while others call for more research and evidence.

community For those that have used anti androgens what is your experience?

in Research/Science 18 upvotes 7 months ago

People discussed their experiences with anti-androgens for hair loss, mentioning side effects like chest pains with RU58841 and skepticism due to lack of safety data, while considering Fluridil as a potential addition to treatment. Some users expressed reluctance to use these chemicals.

community What do you think will be the next "big innovation" regarding AGA?

in Research/Science 10 upvotes 5 months ago

The conversation discusses potential new treatments for androgenetic alopecia (AGA), including verteporfin, pyrilutamide, and hair cloning. There is optimism about scientific advancements providing alternatives to minoxidil and finasteride.

community No, Finasteride as a treatment for MPB was not an "accident"

in Research/Science 105 upvotes 3 years ago

Finasteride was intentionally developed to treat BPH and later approved for male pattern baldness (MPB) due to its 5AR inhibition effects. The delay in MPB approval was due to concerns about off-label use for female hirsutism and the prioritization of treating a more debilitating condition.

community Why do I have the feeling that this subreddit is flooded by Kintor employees?

in Chat 132 upvotes 3 months ago

Users discuss aggressive promotion of Koshine 826, suspecting Kintor employees are behind it. Concerns are raised about its effectiveness, with some preferring alternatives like finasteride and minoxidil.

community Red light therapy - research says they work, reviews say they don't - Turns out commercial device are severely under-powered, so could this actually work?

in Technology 74 upvotes 1 year ago

The conversation discusses the effectiveness of commercial Low-Level Laser Therapy (LLLT) devices for hair growth, suggesting they are underpowered compared to the ideal energy output shown in medical research. A user plans to build a custom helmet that meets the required specifications for effective treatment.

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 42 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 65 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 26 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 4 weeks 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 165 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 6 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.