FDA compounding approvals!!

The FDA's career staff tried everything in their power to stop the approval.

Source: I watched big chunks of the hearing. It was lengthy and, for the most part, depressing.
 
They put in tons of effort to stop it, yet never bothered to research anything for the hearing itself. A few of the things they said ranged from laughable to downright horrifying.
 
I nearly had a PTSD flashback to 8th grade civics class.

The meeting came across as amateur hour to me. I kept waiting to hear the following.

This peptide, currently blocked from research, lacks sufficient human data for approval to research it. Bring more human data so we may consider whether to approve it for possible research in humans.

I might be exaggerating by about 1%...
 
The FDA hasn't given any approvals, and the situation remains exactly as before. That committee was only an advisory group with no binding authority. The headline is misleading clickbait.
 
Sure, the FDA process has only moved ahead by 1 stage.

Yet the headline never claimed the whole FDA had given the green light.

Nor did it state that only 1 branch of the FDA had done so.

The headline simply reads FDA Compounding Approvals.

My guess is that it was intended to say, or ought to say...

FDA Compounding Committee Approval.
 
Even if these end up offered as compounded preparations, they still lack FDA drug approval — meaning there are no high-quality trials establishing their safety and effectiveness, unlike what is required for practically every other medication. That is not to claim they are ineffective or inert; it simply reflects that the necessary studies have not been conducted, so no definitive statement about their safety or efficacy is possible.
 
A run-of-the-mill peptide will never secure FDA approval. Explain that to us, google.

"Bringing a completely new drug through FDA approval generally requires 10 to 15 years and carries a fully capitalized average price tag of $2.6 billion, although the real out-of-pocket expense for one drug that makes it through can fall anywhere from $150 million to $1 billion, varying with the drug category and therapeutic field."
 
Just A Cat said:

A run-of-the-mill peptide will never secure FDA approval. Explain that to us, google.

"Bringing a completely new drug through FDA approval generally requires 10 to 15 years and carries a fully capitalized average price tag of $2.6 billion, although the real out-of-pocket expense for one drug that makes it through can fall anywhere from $150 million to $1 billion, varying with the drug category and therapeutic field."
Click to expand...
That's the reason a patentable analog gets developed instead — like CB-4211, the shelved MOTS-c analog, or tesamorelin, which the FDA has approved. Extra credit when the pk is better.
 
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