Pharmaceutical International News - November 2012
Sandy Affects FDA Drug Approval Deadlines
Posted by Paul Fiddian - Pharmaceutical International's Lead Reporter on 05/11/2012 - 10:00:00
The US FDA's standard new drug approval/rejection timeframe slipped by a maximum of two days during the time Super-storm Sandy hit, the regulator announced in early
Specifically, the FDA - which assesses all pharmaceutical products intended for sale in the US - has said drugs with 29 October or 30 October decision deadlines will definitely now be delayed.
Those with later decision deadlines are still now being considered but, if the approval/rejection verdict is put back, it'll only be by two days maximum, as the FDA swings back into action following its closure during the storm period.
Prior to being relabelled a super-storm, Sandy was the largest hurricane to ever pass along the Atlantic, with gale force winds swirling out around 750 kilometres each side of its central eye.
Super-storm Sandy impacted massively on transport operations in particular, with New York's key airports shut down completely. Meantime, it's so far caused 185 fatalities and caused upwards of $50m worth of structural damage.
FDA Drug Deadlines
The US Food and Drug Administration has pre-determined timeframes set to carry out its regulatory reviews. Drug manufacturers lend financial support to the programme that governs these timeframes and, in return, the FDA works to achieve key goals. For example, it's compelled to have completed a specific number of reviews within a guaranteed length of time.
This programme - PDUFA (the Prescription Drug User Fee Act) - is closely monitored by drug developers since, for one thing, it can tell them when to launch new product promotions.
In related news, the US Food and Drug Administration has released guidelines for US East Coast residents concerned that Super-storm Sandy might have damaged their home drug supplies.
Published by its CDER (Center for Drug Evaluation and Research) division, its Safe Drug Use After a Natural Disaster page covers several issues including Drugs Exposed to Excessive Heat, Drugs Exposed to Unsafe Water and Drugs That Need Refrigeration.
Image copyright Mk2010 - Courtesy Wikimedia Commons
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