News Medical14h
The benefits and challenges of FDA Fast-Track and Accelerated Approval in drug development
Expediting the review process allows for appropriately timed advice and implementing adjustments that considerably reduce the ...
Abolish the FDA (opinion)
Many seriously ill people die waiting for the FDA to approve drugs that regulators in other advanced countries have already ...
National Review8y
Has the FDA Seen the Light on Expediting Its Drug-Approval Process?
Won’t Serve in Admin The New York Times has a story about how an FDA regulator’s wife’s tragic fight against cancer opened his eyes to the need to speed up the process for drug approval: In ...
Acsh.org2mon
FDA drug approval process
The other day on Fox News’ Jesse Waters Primetime, Calley Means, co-founder of TruMed, a B2B company [1], spoke on how to get the corruption out of scientific guidelines and get at the root ...
Hosted on MSN7mon
Supreme Court medication abortion case threatens ‘seismic shift’ in FDA drug approval process, experts warn
has created a trusted drug approval process that could be upended by a case about the medication abortion drug mifepristone that’s being argued Tuesday in front of the US Supreme Court, according to ...
Reuters13h
US FDA approves PTC Therapeutics' gene therapy for ultra-rare disorder
PTC Therapeutics' gene therapy is already approved in the European Union, Great Britain, and Israel. The drugmaker will also ...
Medscape6d
Why a Failed Confirmatory Trial May Not Mean a Failed Drug
there are 64 oncology drug indications on the US market with accelerated approvals only. The FDA estimates the accelerated ...
After decades, FDA finally moves to pull ineffective decongestant off shelves
In a long-sought move, the Food and Drug Administration on Thursday formally began the process of abandoning oral doses of a ...
pharmaphorum2d
The evolving role of AI in drug submission and approval: An expert perspective
The integration of AI into drug submission and approval processes signifies a shift towards more efficient pharmaceutical development. The potential benefits are substantial, including faster ...
Forbes11mon
FDA Approved A New Weight Loss Drug Zepbound. Here’s What To Know And Expect
which is the process of mixing or altering the ingredients of a drug. This precisely occurred with the surge and popularity of Ozempic, a GLP-1 FDA approved drug for diabetes but often prescribed ...
Hosted on MSN10mon
FDA approves medication that extends the lifespan of dogs
Loyal has been working on the medication for four years with hopes to eventually give dogs several extra good years once the drug is ready ... gets closer to full FDA approval.
WBRC FOX6 News16h
FDA bans certain synthetic dye from cosmetics but allows in food, advocate calls it ‘illogical’
that have been approved. “The FDA recognizes that there’s a problem, so they have begun to formulate a plan to put a system ...