Hoping for a New Drug to Cure Your Terminal Illness? Fuggetaboutit, the FDA is gutted.
The development of new drugs depends on highly trained and highly ethical scientists at the FDA who oversee both safety and effectiveness. Sometimes they miss, but if you've been cured of cancer or some other disease, the reason behind it is the FDA, an essential regulatory agency.
Well it seems that the orange slime mold in the White House has not only worked to destroy something beyond his little withered brain, science in general, but specifically, he's gutted the FDA:
'An unwinnable situation': FDA delays force one biopharma to shelve phase 3 plans, WSJ reports
Women’s health company Daré Bioscience planned on launching a late-stage study this year for an investigational cream designed to treat a sexual arousal disorder in women. But, after experiencing delays at the FDA, the company is postponing the trial and instead looking to bring a compounded version of the drug to market this year, CEO Sabrina Johnson told the WSJ and confirmed with Fierce Biotech.
“Women shouldn’t have to wait for solutions—we will continue to innovate and expand treatment options that improve outcomes for those who need it most,” Johnson said in an April 17 post on LinkedIn.
At the end of last year, the California-based company said it had aligned with the FDA on key study design features and endpoints to test Daré’s investigational topical cream formulation of sildenafil (sold as a pill for men under brand names Viagra and Revatio). At the time, the biopharma said it planned on submitting the protocol and statistical analysis plan to the agency in the first quarter of 2025, with a trial launch slated for the middle of this year.
The first quarter has now passed, and Daré says it is still waiting on a piece of information from the FDA related to the analysis plan.
In the last two months, the agency pushed the date it would provide guidance back twice, the Daré CEO told the WSJ. The feedback the biopharma has received from the agency was “brief” and required further discussion, Johnson said...
Now, of course, the source of this article is the Wall Street Journal, which is owned by the dangerous immigrant who has worked tirelessly to destroy the United States, Rupert Murdoch, so of course the article is a drug addressed to sex lives, but trust me, the gutting of the FDA will damage the pharmaceutical industry's ability to treat fatal diseases, debilitating diseases, infectious diseases, etc., etc.
If you were hoping for a cure, the orange idiot wants you to go fuck yourself.
It's disgusting..
= new reply since forum marked as read
Are they still measured in shelf-yards? Or are NDAs submitted online these days?
Of course, looking at it from a pipeline perspective, stopping all research funding kills off the programs where new reviewers come from.
Good thing they're handing over drug development to AI, huh.
