5 Takeaways From FDA Overture On Generic-Drug Approvals

Law360, New York (January 24, 2014, 8:05 PM EST) -- The U.S. Food and Drug Administration signaled Wednesday that it’s taking customer service to heart now that generic-drug makers are paying for faster approvals, inviting reform proposals that experts say industry will be more than happy to provide. 

In a request for comments, regulators cited more than two dozen “common, recurring deficiencies” in so-called abbreviated new drug applications and offered to address any root causes. While lawyers generally welcomed the agency’s offer, they also described it as merely a down payment on an overdue regulatory overhaul....
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