Blog & Resources Camargo Blog March 28th, 2008

Approval Delays at FDA

One of the expected benefits of the new drug approval process under PDUFA is that drugs get approved within a certain timeframe, today about 10 months after submission. This often cited as a reason why generic companies are looking at 505(b)(2) – generic approval times are now stretching to 20+ months. Now comes the news that FDA is going to allow up to 10% of applications to miss the PDUFA deadlines and also miss the meeting deadlines [I usually provide a reference to the original, but the sources cite an internal FDA letter by John Jenkins].

Why the delay? FDA is getting more money, is authorized for 500+ people but HHS decided to take new employee processes away from FDA, resulting in decision delays. Reportedly, prospective employees give up waiting.

We continue to believe that a well-prepared meeting request will get scheduled before incomplete requests and that a very well done submission will get approved on time.

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