Lachman CONSULTANTS - Bob Pollock先生 2014-06-16
校译：识林-柯 2014-06-18
The Blip Before the Blip – 134 ANDAs Received in May
Written by Bob Pollock • June 16, 2014
Looking more typical of a December number of ANDA submissions, the May 2014 number of 134 is just a blip before (what we believe will be) a very big June. Remember that firms will be hustling to get ANDAs in before the new stability requirements go into effect on June 20, 2014.
I reported last week that the Office of Generic Drugs (OGD) only approved 20 ANDAs in May; however, with the posting of the full May statistics on the FDA website, I can also tell you that OGD refused to receive 20 ANDAs, the second most in any month this fiscal year (30 in October 2013).
Now we are 8 months into this fiscal year and already OGD has received 805 ANDAs in that period. We have another big month (as noted above) expected in June, then there will be the September rush to beat the fee increases (unless the fees dip due to an unexpected increase in ANDA submissions). If the fees do decline for ANDAs, and, with a lure of year three metrics and perhaps being one of the 60% of the ANDAs reviewed within 15 months, firms may decide to hold off in September for that chance. The new fees will be out soon and it will be interesting to follow that issue and see how it impacts submissions.
If we simply straight-line the first 8 months receipts of 805 ANDAs, then expect the full fiscal year’s submissions to be just a little over 1200 ANDAs – a new record at a time of many new challenges!
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法规指南解读：ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers
