Fast-track drug approval process marked for limited changes

A week after the maker of a controversial Alzheimer's drug announced it would largely stop marketing it, Congress is readying legislation that tinkers with the pathway used by the FDA to approve the drug, but avoids making large-scale changes.Aduhelm's approval created heightened scrutiny around whether the FDA's "accelerated approval" process is being used appropriately. But as the drug fades largely into the background, so are the calls for stringent reforms.

But the process has drawn concern because of the way it could put big-ticket drugs in the public's hands that may wind up being ineffective or unsafe. The bipartisan legislation also clarifies conditions under which the FDA could withdraw an accelerated approval and adds labeling requirements for drugs that go through the process.Democrats and Republicans were divided over how far to go, with Democrats in favor of putting more of the onus on manufacturers to justify keeping the approvals and Republicans wanting to expand the use of the pathway, per Cowen analysts Eric Assaraf and Rick Weissenstein.

yeah let me sell you a sugar pill to my patients who cannot remember if it works or not lol

United States Latest News, United States Headlines

Similar News:You can also read news stories similar to this one that we have collected from other news sources.

Fast Food Is Using Your Favorite Rapper to Infiltrate Your Mind and WalletBTS, Travis Scott, Megan Thee Stallion, and Doja Cat have all recently launched fast-food partnerships at McDonald’s, Popeyes, and Taco Bell
Source: Eater - 🏆 368. / 59 Read more »

8 Ways To Reduce Bloating Fast, According to These GI DoctorsMoving your body can also help move gas out of your digestive tract.
Source: POPSUGAR Fitness - 🏆 401. / 53 Read more »

1 dead, several people hurt in fast-moving house fire in BronxCell phone video from a neighborhood resident showed one home completely engulfed in flames. yeah.
Source: ABC7NY - 🏆 592. / 51 Read more »

Chicago casino selection process moving too fast, some aldermen complainThere's a push for the committee to vote on the plan later this month. Is that gollum?
Source: ChicagoBreaking - 🏆 521. / 51 Read more »

Why Narcissists Want What They Want, and FastPeople who are narcissistic often have trouble waiting and expect their desires to be met instantly. Here's how that affects their relationships—and what to do about it, writes swhitbo swhitbo I am a narcissistic ? 🤦🏽‍♀️😲 swhitbo Ha! Are you a narcissist? So you think your better than Dr. Todd grande? Aka Dr Big Todd!?
Source: PsychToday - 🏆 714. / 51 Read more »

'This Is Us' Fast-Forwards to Rebecca's Final DaysAs the series prepares for its curtain call, Tuesday's episode catches everyone up as the family gathers together to say goodbye.
Source: etnow - 🏆 696. / 51 Read more »