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出自识林

2015-08-06 Lachman CONSULTANTS

仿制药办公室7月完全批准47件ANDA、暂时批准12件ANDA，共59件批准行动。尽管完全批准量较上月GDUFA最高57件有所降低，不过，这一批准量已代表了OGD超过平均水品的月度批准工作。

7月份申请接收量为40件，因此，OGD可以设法保持批准量超过接收量，从而减少积压。即使每月净减少19件ANDA，徘徊在4000件左右的积压情况也将持续相当长一段时间。如果OGD希望消除未决申请的积压，批准工作应不断加速。

随着新GDUFA2016财年收费标准公布，ANDA申请费上涨29%，我们怀疑在2015年10月1日新收费标准生效前将会涌现大量申请提交。又或者ANDA申请人即使面对更高的申请费也决定暂缓提交ANDA，以便享受到第4年队列的指标 – 要求OGD在15个月内审评在GDUFA第4年队列提交的75%的ANDA？是更高费用的差价，还是在15个月时间框架内被审评机会增大15%，哪个因素将推动企业的选择，我们拭目以待。

从更积极的方面，FDA月度批准网页已经列出在8月3-5日3天工作日内10件完全批准和1件暂时批准。这无疑是本月一个很好的开端。

Lachman CONSULTANTS - Bob Pollock先生 2015-08-06
编译：识林-椒
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Office of Generic Drugs' July Numbers Are In
By Bob Pollock | August 6, 2015

The Office of Generic Drugs (OGD) fully approved 47 ANDAs and Tentatively Approved 12 ANDAs for a total of 59 approval actions. While the number of full approvals falls below last month's GDUFA high of 57, nevertheless, it represents an above average month for approvals for OGD.

The number of receipts in July was 40, and, thus, OGD managed to keep ahead of the receipts and will have the net effect of reduction of the backlog. At a net decrease of 19 ANDA/month the backlog that is hovering around 4000 will be around for a long time. Approval numbers really need pick up steam if OGD hopes to eliminate the backlog of pending applications.

With the new GDUFA FY 2016 fees just announced and an increase of 29% in the ANDA fee, we wonder if we will see a big push to get applications submitted before the new fees go into effect on October 1, 2015. Or will ANDA applicants hold off on submitting their ANDA even with the higher fees, in order to take advantage of the Cohort year 4 metrics that require OGD to review 75% of ANDA submitted in cohort year 4 in 15 months? It will be interesting to see if the differential in the higher fee or the 15% increased chance of being reviewed in a 15 month timeframe will drive industry decisions.

On a more positive note, I noticed that the FDA Monthly Approval site already lists 10 full ANDA approvals and 1 tentative approval with only 3 business days (August3-5) so far this month. This certainly represents a good start for this month.