"It is no longer if, but when and how?", page-9

There's an article I just read that is interesting and something worth keeping in mind with Clinuvil FDA approval processes.

IMO this highlight the kind of hurdles and regulatory bureaucratic inertia that Clinuvel is having to deal with in the US. Not having yet approved something as simple and effective as bemotrizinol gives me good reason to keep my expectation of rapid pipeline approval for Clinuval well toned down.

Here's some extracts from it:

"
While American sunscreens generally do a good job at blocking UVB rays, which cause sunburn, experts and studies have noted in recent years that they often provide weaker protection against ultraviolet radiation in the form of UVA rays, compared to products available in places like Europe and South Korea. Expertsattribute this gap largely to regulatory differences. In the US, sunscreen is classified and regulated as an over-the-counter drug, rather than a cosmetic product like in other countries. This means that each active ingredient must undergo an often lengthy regulatory approval process with the US Food and Drug Administration (FDA) and are subject to rigorous safety requirements and animal testing.

A 2017 study found only around half of US sunscreens tested met the European standards for UVA protection.

Experts often point out that the FDA has not approved a new UV-filter for sunscreen in more than 20 years.

“The issue for me isn’t the safety of the sunscreens we have,” dermatologist Adewole Adamson told NPR. “It’s that some of the chemical sunscreens aren’t as broad spectrum as they could be, meaning they do not block UVA as well. This could be alleviated by the FDA allowing new ingredients.”

Meanwhile, in countries like France, South Korea, the UK and Japan, governments have approved a wider range of UV-filtering ingredients, which experts say allow for more advanced sunscreens.

One of the ingredients is bemotrizinol, which is considered one of the safest and most vetted chemicals on the global market.

It remains unapproved by the FDA, but Swiss sunscreen company, DSM-Firmenich, is seeking FDA approval for it.

But, dermatologist Dr Nazanin Saedi told Axios that a decision is not expected before 2026.
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