Despite 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.
About the Author Reprints
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.
FDA GOES WHERE THE MONEY IS, JUST LIKE THE DEM O RATS
FDA should be practicing Quality by Design it has been teaching the industry to follow in their application filing and approval process. It is time.
ANDA (Abbreviated New Drug Application) / NDA (New Drug Applications) Filing Simplification: Road Maps are a Must.
https://pharmachemicalscoatings.blogspot.com/2017/05/road-maps-for-simplification-of-anda.html