首页 > 资讯 > 三月 - FDA仿制药批准持续低迷

出自识林

2015-04-08 Lachman CONSULTANTS

4月7日显示FDA三月份的月度批准清单仅有14件批准和4件ANDA暂时批准。诚然，与庞大的积压相比，ANDA的数量正在下降，作为前FDA人员非常难以理解仿制药办公室（OGD）与Hatch-Waxman目标相关的关注点。我完全明白GDUFA目标是OGD绩效的要求，但如果ANDA没有获得最终批准，完全回应函和OGD在达到所有GDUFA目标方面的成功对于仿制药企业可能相当空洞。

现在，也许FDA月度批准报告 url并不可靠或不准确，或者并不是最新的。也许三月实际还有更多的批准（尽管清单显示最后的批准是在3月30日），但这是我们在企业的人能够得到的唯一的数据。如果情况确实如此，那么这会引起持续担忧。如果不能准确地报告OGD效率数据，企业如何能知晓OGD正在实施的新的审评模式的工作进展，并查看OGD确实在工作？

GDUFA的第三年已经过去6个月，这个月是自GDUFA实施以来批准量最少的月份，这肯定会让一些CEO感到有些紧张。

Lachman CONSULTANTS - Bob Pollock先生 2015-04-07
编译：识林-椒 2015-04-08
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If You Can Believe the FDA Monthly Approvals Page – The Corner May be Further Down the Road for OGD
Written by Bob Pollock • April 07, 2015

Today is April 7, 2015, and the FDA Monthly Approvals list for March shows only 14 approvals and 4 ANDA Tentative Approvals. Granted that the number of ANDA is declining, with the whopping backlog, it is hard for this former FDAer to understand the focus of the Office of Generic Drugs (OGD) relative to the goals of Hatch-Waxman. I totally recognize that the GDUFA goals are mandated for OGD's performance, but if the ANDAs are not driven to final approval, the Complete Response Letter and OGD's success in meeting all of its GDUFA goals may be rather hollow for the generic industry.

Now, maybe the FDA Monthly Approval report url is not as reliable or accurate, or as up to date as it should be, and perhaps there were actually more approvals in March (albeit the last approvals listed are for March 30th), but that is the only data we have out here in industry to work with. If that is indeed the case, then there is a real continued concern. Without accurate reporting of OGD productivity data, how can the industry have a view into the progress that OGD is making in implementing the new review paradigm and to see if it is indeed working?

Here we are 6 months into year three and to see the fewest number of approvals in any month since GDUFA was implemented is certainly making some CEOs a bit nervous.