D

espite what some critics may say, Food and Drug Administration staffers do not need Geritol in order to speed product reviews, at least according to a new analysis.

After examining all 15 drugs approved between 2011 and 2015 by the cardio-renal division — purportedly, the slowest of FDA divisions — a pair of researchers believe there is “limited opportunity” to speed approvals by reducing the time taken for agency reviews and decision making. Instead, the authors suggested that drug makers could move more quickly to prepare applications.

This is a STAT Plus article and is only available to STAT Plus subscribers.
To read the full story, subscribe to STAT Plus or log in to your account.
Good news: your first 30 days are on us.

Leave a Comment

Please enter your name.
Please enter a comment.

  • We cancer pt. rights activists have seen an improvement in FDA approvals- more flexibility with data, better listening to our concerns . Since 2014 . Those researchers cited here didn’t look at cancer drug approvals . The FDA made a series of mistakes between 2009 and 2014 – with kadcyla, iclusig and the MS drug lemtrada . They tried to change the end line and push for overall survival vs. progression free – but they were working in a 7 – 10 year long 20th century approval system . We pt.’s revolted . The mistakes highlighted the overall slow FDA system . So, the FDA Oncology Drug Products Review Division of the 2009 – 2014 era needed not just a ” pep pill ” but a kick in the a–. And they got it : with pt. protest , social media petitions and Right To Try.

  • A GS 14 FDA reviewer makes $88,000/yr versus his pharma bro who makes 2X. At those wages living in the DC area I would also start my weekend at noontime Thursday.

Recommended Stories

Sign up for our biotech newsletter, The Readout

A guide to what’s new in biotech — delivered straight to your inbox every weekday morning.