OGD发布2014财年最终统计数据
出自识林
OGD发布2014财年最终统计数据
笔记 2014-10-09 Lachman CONSULTANTS Activities Report of the Generic Drug Program (FY 2014) 回顾完全回应函（CRL），9月为全年最低月有75件，仅比2013财年最低月份3月的73件多出2件。2014财年CRL总量仅比2013财年略高，各自为1254件比1251件…，但今年比上个财年有显著的人员增加。这很可能继续反映了培训新员工的高时间成本，以及培训负荷造成的效率低下。当培训周期接近结束时，效率很可能会提高，但企业还需要等待多久？ 2014财年拒绝接收（RTR）的发布显著较高，173件相比2013财年107件。这很可能意味着2013财年年底公布的RTR标准的严格性增加。 2014财年CRL后GDUFA会议请求共计85次，举行了60次会议，总计85次的请求中仅8次拒绝、3次取消、11次未决、3次批准。会议请求平均似乎是每月5-6次。 虽然我不能肯定我在GDUFA第2年的这些数字中看到了很多好消息，第3年的指标可能会进入新的现实。让我们期望对第1和第2年的申请不收集指标的理由（因为增加雇佣和培训对资源的消耗），变为OGD军团准备好迎接GDUFA指标年的挑战。 另外一个有趣的消息是，预计2014年10月1日之后会出现另外一个申请提交高峰，企业可能在能够利用到第一个指标年的好处之前推迟提交。迄今为止，OGD还没有看到任何异常的繁忙。我们将继续跟进这一问题。原因之一是，这一繁忙尚不能与2014年6月的刺激因素相提并论，而且其他申请仍在等待生成（现在必需）6个月的加速和室温稳定性数据以提交文件。 总之，GDUFA的头两年让业界非常担忧。第3年可能是一个突破年，但OGD仍在公布剩余的招聘职位并整合到项目中。OGD正在聆听业界的忧虑，并试图解决，即使其中一些问题在GDUFA目标函之外。他们的成功取决于目标，但业界将密切关注进程中的更多迹象。 Lachman CONSULTANTS - Bob Pollock先生 2014-10-09 识林www.shilinx.com，版权所有，如需转载请注明出处 FY 2014 Final Statistics for OGD Released With a record number of ANDAs received by the Office of Generic Drugs (OGD) and a modern day record low number of approvals, we move into FY 2015 still looking for the bright spot. OGD received 1473 ANDAs for FY 2014, which included a record 635 monthly receipt record and two monthly low receipt records of 4. September saw 25 ANDA submitted. As far as approvals go, the total just surpassed the 400 mark at 406 for the full fiscal year. OGD also issued 91 tentative Approvals in FY 2014 In review of Complete Response Letters (CRL), September saw a monthly low of 75 for the year, which is only 2 more than the FY 2013 monthly low of 73 seen in March of 2013. CRL totals for FY 2014 were only slightly higher than FY 2013, with 1254 vs 1251 respectively….and this is with a significantly staffing increase over last FY. This is likely still reflective of the high time cost of training the new staff and the inefficiency that the training load creates. Productivity is likely going to increase as the training cycle comes to a close, but how long can industry wait for this to happen? Refuse-to-Receive (RTR) issuances in FY 2014 were significantly higher, at 173 vs 107 for FY 2013. This likely signifies the increase stringency in RTR criteria announced at the end of FY 2013. Post-CRL GDUFA meeting requests totaled 85 in FY 2014 with 60 meeting being held, only 8 denied and 3 cancelled and 11 pending, and a number of 3 granted rounds out the 85 total requests. Meeting requests appears to be averaging around 5-6 per month. While I am not certain I see much good news in the number for year two of GDUFA, year three's metrics will likely kick in the new reality-let's hope the rationale for not collecting metrics on applications for year 1 and 2 (due to the ramp up in hiring and the drain on resources that training requires) translates into an OGD corps ready to meet the challenge of GDUFA's metric years. One other interesting factoid is that we expected another rush after October 1, 2014 in application submissions for firms that may have delayed submission until then to take advantage of the first year of metrics. So far, according to OGD, they have not seen any abnormal rush. We will keep track of this issue. One reason that this rush has not yet been seen could be related to the big June 2014 push and other applications still waiting for the generation of the (now required) 6 months of accelerated and room temperature stability for filing. All in all, the first two years of GDUFA have the industry very concerned. Year three may be a breakout year, but OGD still has the remaining hires to be brought on board and assimilated into the program. OGD is listening to industry concerns and is trying to address them, even though some of the issues are outside of the GDUFA goals letter. Their success is dictated by the goals but industry will be watching closely for even more signs of progress. |