首页 > 资讯 > GDUFA实施以来受控函数量持续上升

出自识林

2016-07-21 Lachman CONSULTANTS

发送到FDA仿制药办公室的受控函（CC）数量似乎自GDUFA实施以来逐年递增（请见下表）。表中的数字来源于GDUFA计划实施以来相应财年的仿制药计划行动报告。

受控函数量的增加很可能是由于《与仿制药研发相关的受控函行业指南终稿》和MaPP5200.3版本1的发布。指南终稿对受控函是什么以及实际上谁可以提交具有60天GDUFA目标日期的受控函做了限制。好消息是OGD正逐渐赶上对受控函的回复，但坏消息是受控函数量正继续飙升。

*截止2016年5月
**预期2016财年全年

数量增加的部分原因可能与OGD重组和指南实施之前许多问题由OGD工作人员做出非正式回答有关。可以理解的是，出于一致性目的以及回复的质量控制，FDA希望记录对问题的回复。然而，业界有抱怨表示一些对受控函的回复实际上并没有回答所提的问题，或仅仅让请求者参看OGD认为能够解答所提问题的指南文件。如果请求者需要进一步信息，可能会产生另一封受控函和重启回复时钟。这对于企业来说是令人沮丧的，对于FDA来说耗时耗力。或许可以有电话会议的选项来解决其中一些问题。至于给行业的建议，请确保受控函是明确的，具体确定需要回答的问题，并且如果指南中的一些内容不清楚，足够详细地描述问题，从而OGD可以提供更有针对性的回答。

Lachman CONSULTANTS - Bob Pollock先生
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Controlled Correspondence On the Rise Since GDUFA Implementation
By Bob Pollock | July 19, 2016 原文地址

The number of Controlled Correspondence (CC) sent to the Office of Generic Drugs (OGD) appears to be rising from year to year since the implementation of GDUFA (see chart below). The numbers in this table were derived from the Activities Report of the Generic Drug Program for the respective Fiscal Years so far under the program.

The increase likely is due to both the final Guidance for Industry on Controlled Correspondence (here) and the MaPP 5200.3 Rev 1 (here).

The Final Guidance referenced above put limitations on what a Controlled Correspondence is and who may actually submit one that will have a GDUFA goal date of 60 days. The good news is that OGD is keeping up with its responses to Controlled Correspondences but the bad news is that the number appears to be spiking, as illustrated in the table below.

*Thru May 2016
** Projected for full FY 2016

Part of the increase may relate to many questions being answered informally by OGD staff prior to the OGD reorganization and implementation of the Guidance document. It is understandable that FDA wants responses to questions documented for consistency purposes as well as for quality control of responses. However, industry has complained that some of the responses to the CCs do not actually answer the question that was asked or simply refer a requestor to a Guidance document where OGD believes the answer to their question lies. If the requestor needs further information, it may generate another CC and may start the clock over again. This is frustrating for the industry and time- consuming for FDA. Perhaps there can be a telephone conference option to resolve some of these issues. As for advice to industry, be certain that your CCs are clear and that you specifically identify the question you need answered and, if there is something in a Guidance that is not clear, describe the issue in sufficient detail so that OGD can provide a more targeted response.

Please let us know what your experiences have been with the CC process and OGD communication in general over the last year. Have things improved? We would be interested in your feedback.