It’s that time of the year again. We max out our credit cards, drink eggnog, bake cookies, revel with family and friends, and look back on the year that just passed. We hope you had a great year, and hope that the holiday season provides warmth and good tidings to all and the New Year brings you good health, happiness, and prosperity.
And now a little “year in review” (sung to the tune of Winter Wonderland)!
COVID’s still here, but we’re no longer listening.
Vaccine boosters have us bristling.
We hope you’re all right, with no flu in sight,
As FDA renews inspection‑land.
They’re coming in your firm’s front door,
As they look for schmutz on your floor.
A 483 in hand, a Warning Letter planned,
Back again in FDA inspection land.
The patent thickets are a block to progress,
As biosims have trouble gaining market egress.
FDA grants them approval and the courts say no man,
But with FTC can do the job and give them redress.
UFA fees keep on rising, the story seems reprising.
Industry pretends they’re getting more,
But are they really sure?
Just think–only five more years to reauthorization land!
Orphan drugs are getting such surprises.
The uncertainty of the benefit really rises.
The court disrupts FDA view and, with hat in hand,
The decisions are delayed in FDA‑land.
Surrogate endpoints relied on for accelerated approval,
Are certainly starting to often end in drug removal.
Confirmatory studies take too long, and if Congress sings its song,
There might be big reforms in FDA‑land.
But all is not lost as we look here.
This brings us a reason for some good cheer.
Approvals keep coming along, and that’s really something strong,
As we all review the past year we’ve had in FDA‑land!
Happy holidays to all and keep on singing a tune that makes you merry! Hope you enjoyed this little ditty’s reprisal, and a Happy New Year to all.
