"If a drug is designated as breakthrough therapy, FDA will expedite the development and review of such drug. All requests for breakthrough therapy designation will be reviewed within 60 days of receipt, and FDA will either grant or deny the request. "
Know what would be super awesome? How bout they review every damn application for every indication within 60 day . Hell better yet why not 30 days, or even God forbid two weeks. Think that's not a big part of the problem, then why the heck is a Pediatric Priority Review Voucher worth ~$350 million when all it does is force the FDA to do their job in an expeditious manner. If your local grocery store was continually understaffed and it took forever to checkout, then you would likely go to another store. Imho a big part of the problem is that Government has a monopoly on the process if they want to make you wait.... then guess what, you wait, cuz you ain't got no other option. Somehow a private business mindset needs to be brought in to their bureaucratic fiefdom imho.
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