Page 3 - Fda Approval Process News Today

Kimberly C. Chen DO, MSHLM, and Maia Kayal, MD, MS, review the challenges related to biosimilars from the payer perspective and strategies payers may employ to help improve the uptake of biosimilars.

Of one of the pills that is used in medicated abortions. where a judge in washington state said no it can move forward. justice alito has put the texas ruling on hold for now. the biden administration is fighting it. they went to the court and said there will be chaos if women cant get access to the pill. now the justice has asked the other side to weigh in. they have to file their briefs by tuesday in this case. by wednesday, we could have a decision that quickly on what happens moving forward....

It says he has top secret security clearance. that tells me nothing. he could be either state national guard or federal national guard. i believe this is the next shoe to drop. i mean, i believe as we learn more, we will either determine you know, for reasons that are inexplicable to me that he was a state national guard member. having access to information as almost no relevance to a state national guard or possibly that he had been federalized under title 10 status, in which case the pentagon ...

You know what i wanted, but i knew in my head what was i should do. and so after weeks of contemplation, praying to my god speaking to my clergy, you know , i made the decision to, um to go through with the procedure. but i kept praying. make the decision for me to make the decision for me. and when i went for that, you know the ultrasound again. luckily god made the decision for me. and the pregnancy terminated on its own. and i was grateful for that. but do you know what i was really grateful ...

Somebodys home had been locked and somebody who had a copy of the key then decided to break back into that home. i mean, is it as simple as that? is this sort of like an honor system when it comes to national security issues. i mean, it is in some ways because you would hope, but that honor system is based on verify verify entrust right and the verification is not just the clearance itself. its continuing reviews throughout the process. it is it is, too. they travel abroad. are they all of a sud...

Access that its had, but also because of the fact that this ruling just a week ago by this judge in texas, called into question the fda approval process. this drug was approved in the year 2000, and there has been a fair amount of data since then, in terms of feedback about the impact on women and how safe it is. so this is also a major focus because its going to involved potentially the fda approval process. absolutely this is, you know it was as far reaching beyond abortion access to the fda a...

Could act fast here. you know, because really guys if they dont the entire way this abortion pill is administered would change virtually overnight . it would still definitely be available. but there would be these drastic changes that the fda has laid out. you know, theyre saying that theyre unsure how exactly they would handle it. if the fifth circuit ruling goes into effect, and theyre saying that this is really a process that demands just a lot more than just a flip of a switch. so the doj ha...

For good public health policy to allow courts and politicians to tell the fda what it should do. >> reporter: the judge appointed by president trump issued a 67-page opinion, asserting the fdas approval 23 years ago violated a federal rule because the drug wasnt properly tested . the ruling could limit abortion access even for women in states where the procedure is legal. anti-abortion advocates are pleased with the decision. >> we are encouraged the judiciary is ftaking a look at the approval o...

The drug used will be off markets in all 50 states. at least during the period where the injunction is in force. >> dr. krystin brandi says patients will be able to get a medication abortion even if theg is banned by using the other drug and a combination >> its a little bit less effective. maybe side effects were people needing additional care. >> meg influences the outcome may undermine the fda approval process, setting damaging precedent. meg oliver, cbs news, new jersey. >> norah: here in wa...

In europe have been growing healthy for decades, so i cant imagine a situation where there would be some drastic change from what were doing here. i think here in america, it just has to do with the fda approval process and why that hasnt really been done before because frankly, weve never needed it until this period. so, im hopeful that once it comes in, its going to be safe and effective and those babies will get that nutrition that they need. >> dr. blake bergeron, really helpful information....