首页 > 资讯 > FDA回答了受控函草案的评论

出自识林

2015-07-01 Lachman CONSULTANTS

2014年8月,FDA首次发布了《仿制药研发的受控函》指南草案，我们当时也有资讯在这里。在今天的联邦法规中，对指南草案收到的评论/意见，FDA进行了公开回答here 。

大致来说，评论是很少的，主要是关于“GDUFA目标例外的受控函”。确切的说,这些有疑问的例外的情况（以下3条是指南草案中的原话）是：
（1）要求具体产品生物等效性（BE）研究设计的意见（要求BE指导）
（2）要求BE临床方案审核（临床方案要求）
（3） 在ANDA递交前，要求仿制药研发讨论会（ANDA前会议要求）

FDA回复这些评论说“对BE指导、临床方案审核、ANDA前会议要的考虑，FDA没有改变政策。一旦收到电子递交，FDA将迅速考虑，并根据实际情况尽快回复。尽管指南指出这些要求不认为是受控函，但是BE指导、ANDA前会议要求是包含在这1020个总年度回复中的（见表1：估计的年度任务），因为这些要求使用了相同的收集途径 – 即：受控函要求途径。然而，因为指南草案描述的原因，受控函的GDUFA量度将不会包括FDA对这三种例外情况的回复。”

上述提到的表1包括了，FDA估计收到受控函的单位/企业数量是217个，基于往年情况，FDA预计每个单位会递交平均4.7个受控函，向FDA要求指导。

针对复杂或不一般的情况，得到完整的递交、得到有价值的指导，对FDA是更多的工作，这是“必要之恶”。对于有GDUFA目标的受控函，我们没有见过FDA是怎么处理回复的，但是按照仿制药办公室的说法，他们一直都达到并超越GDUFA目标。

Lachman CONSULTANTS - Bob Pollock先生 2015-07-01
编译：识林-榕 2015-07-01
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FDA Addresses Comments on its Controlled Correspondence Guidance
Written by Bob Pollock • July 01, 2015

FDA first released its guidance on Controlled Correspondence Related to Generic Drug Development in August 2014. We previously blogged about this guidance (here). In today’s Federal Register notices, FDA provided its response to comments received on the Guidance document. (here ).

Basically, the comments were few and addressed the exclusions to what is considered “controlled correspondence” subject to GDUFA user fee goal dates. Specifically, those exclusions questioned were (1) Requests for recommendations on the appropriate design of bioequivalence (BE) studies for a specific drug product (BE guidance requests); (2) requests for review of BE clinical protocols (clinical protocol requests); and (3) requests for meetings to discuss generic drug development prior to ANDA submission (pre-ANDA meeting requests). FDA addressed the comments by stating “FDA has not changed its policy regarding its consideration of requests for bioequivalence guidance, clinical protocol reviews, and pre-ANDA meetings. FDA will consider them promptly upon their electronic submission and will respond as expeditiously as practicable. Although the guidance states that these requests are not considered controlled correspondence submissions, requests for BE guidance and pre-ANDA meetings are included in the 1,020 total annual responses estimated in table 1 because these requests will utilize the same information collection pathway as a request that is considered controlled correspondence. For reasons described in the draft guidance, however, controlled correspondence GDUFA metrics will not apply to FDA’s responses to the three excluded requests.”

The table referred to above includes the projected number of firms (217) from which the FDA expects to receive controlled correspondence and estimates, based on previous years, that each firm will submit an average of 4.7 controlled correspondences asking FDA for guidance.

More work for the Agency, but a necessary evil to obtain complete submissions and to gain valuable guidance on complex or unusual situations. We have not seen much information on how the Agency is doing with meeting the GDUFA goals for response to controlled correspondence, but according to OGD, they continue to meet or exceed all GDUFA goals.