Page 4 - Fda Approval Process News Today

And there is still such a shortage of testing. this is a failure by the trump administration and the biden administration. as somebody who pursues your own tests as much as you can get them for arkansans, somebody who works with the federal government both trump and biden, what is the problem? why are there not enough tests? >> well, there are plenty of pcr tests. so you can go anywhere and get a test. its just not rapid. and so the shortage is one particular area of tests. >> right. that kind. ...

You could use to basically, you know, mitigate the infection. so that was missing in the fda approval process. they did not have that concept of frequency. nor they had a concept of a test that is not just for diagnosis, like we all know medical professionals need, but also population, something that is called monitoring and that the fda does not regulate and still doesnt have a template or any kind of mandate to companies to do. >> im sorry, dr. hilton, understanding that this test is not as se...

The FDA's recent approval of a new drug, Aduhelm, to clear the formation of amyloid plaques in the brain is potentially good news for the six million Americans who suffer from Alzheimer's disease. But the drug's approval process has stirred controversy.

Opportunities because we -- its part of our commitment to equity. we want to make sure the vaccine is accessible and that every family has the opportunity to protect their children with this vaccine. so pediatricians offices will have it. well have school-based vaccine sites and community vaccine sites as well. >> do you think ultimately it will be a required shot, immunization for the younger age group like it is for some of the older kids in certain schools? >> well, in california, we do antic...

Lightly. can you explain? >> absolutely. you know, as a parent, my first priority is keeping my kids safe and healthy. i want to do everything i can to facilitate that, but i would never want to do anything to put my kid at risk. so i wanted to know the facts and the data. i would never have rushed out and gotten my kid vaccinated before this vaccine went through the fda approval process. i wanted to make sure that it was safe and that it was effective at protecting him and other kids against co...

Streamlining the fda approval process. you mentioned the ten kits. the fewer companies that you have competing, the more expensive the tests. the goal here is to streamline the process and to also pick those manufacturers, geoff, who have the greatest potential to bring high quality testimonials and manufacture a lot of them quickly to give them an expedited pathway for approval. this couldnt come at a more important time because you and i all know were waiting for the presidents osha rule, the ...

Spread of covid 19. >> decades. professor of medicine at stanford. first of all, im not too far from stanford so i hope you feel the 5. did they not push this fda approval too fast especially when you compare it to the normal approval process? they did. normally would take years to get a vaccine tested, approved for the fda approval process, they moved extraordinarily quickly. the full approval of this drug in some sense doesnt change the fundamental issues with the vaccine. we know from experie...

Now, dr. jay bhattacharya, professor of medicine at stanford. dr. bhattacharya, im not too far from stamford right now, so i hope you feel the vibe if you are there. professor, did they not push this fda approval to fast? especially when you compare it to the normal approval process. >> they did, normally it would take years to get a vaccine tested and approved through the fda approval process, they moved extraordinarily quickly. the full approval of this drug in some sense it does not change th...

Mean, in the military, military members get vaccines given to them. why -- why isnt this mandatory, among the military? is it a question of waiting till the fda, actually, has approval as opposed to -- to emergency-use authorization? >> well, this is actually a question the department of defense is, actively, considering. and -- and its important, because youre absolutely right. the military does require, you know, active-duty officers to get vaccinated in -- in many other cases. and i believe i...

The military, military members get vaccines given to them. why is it not, why isnt this mandatory among the military? is it a question of waiting until the fda has approval as opposed to emergency use authorization? >> well, this is actually a question that the department of defense is actively considering and its important because you are absolutely right. the military does require, you know, active duty officers to get vaccinated in many other cases and i believe it would make sense hear, too....