A congressional investigation found that the FDA’s “atypical collaboration” with drugmaker Biogen to approve Aduhelm, a high-priced Alzheimer’s drug, was “rife with irregularities.” ...

It’s a long and arduous process that requires tons of data. Plus, the agency wants to rebuild trust after coming under attack during the Trump Administration. While nearly 190 million Americans ...

So that’s the path to emergency authorization, which Pfizer received in December. Since then, per the standard FDA approval process, the drug maker has kept track of any serious side effects ...

Here’s a step-by-step breakdown of how a drug earns FDA approval. 1. Preclinical phase. Before a drug company can test an experimental treatment on humans, it must prove the drug is safe and ...

Of 174 drugs and biologic therapies approved between January 2012 and December 2016, 105 (or 60%) traversed the FDA evaluation process with one of four designations aimed at speeding the path to ...

As RFK Jr. seeks FDA overhaul, the department leans into 'big data.' advertisement. Mashable. FDA wants to use AI to speed up drug approval process. Story by Chase DiBenedetto • 3w.

Moreover, around two-thirds of physicians thought the FDA's current bar for the approval of new drugs and devices was "about right," at 59% and 66%, respectively, as opposed to too high or too low.

"The FDA recognizes that vaccines are key to ending the COVID-19 pandemic and is working as quickly as possible to review applications for full approval." ...

FDA coronavirus vaccine guidelines raise doubts over approval by Election Day 02:06. The Food and Drug Administration has released its long-awaited guidance on how it will issue Emergency Use ...

The program, which launched in 1992, was designed to speed up the approval process for drugs that treat life-threatening illnesses. That's only if the drug has been proven to have a clinical benefit.

The Food and Drug Administration (FDA) has approved a manufacturing process change for Yescarta ® (axicabtagene ciloleucel) allowing for a shorter manufacturing time.. Yescarta, a CD19-directed ...