Eight FDA Draft Proposals That Seek To Improve Transparency Of GMP Compliance And Enforcement Data

By habits in Smoking on January 25th, 2012

The American Food and Drug Administration (FDA), has in October 2011, revealed eight new proposals to improve transparency surrounding GMP compliance and Enforcement data. In their report the FDA has stated that the proposals focus on making data surrounding compliance and enforcement more accessible and user-friendly. By doing so the FDA hope that they can raise understanding of how they work and also make their decisions. In this article we look at the eight proposals and present them in language that can be easily understood by those that don’t work in the relevant industry.

Draft Proposal 1

FDA to consider how the speed with which data is reported can be increased and the quality of data improved. Ways of achieving this goal could include better technology for investigators, improved processes and administrative incentives. Should also liaise with stakeholders and discuss how frequently data should be updated.

Draft Proposal 2

Although the FDA has an email address that stakeholders can use to raise questions on regarding the database, it is rarely used. Would the ability for stakeholders to use a reporting button to raise an issue of possibly incorrect data improve quality and reduce resolution time?

Draft Proposal 3

Question of whether GMP compliance and enforcement data being presented using graphics and mobile web applications should be considered.

Draft Proposal 4

Investigate whether it would be easier to analyze GMP compliance and enforcement data if it were integrated with other publicly available information.

Draft Proposal 5

Explore the possibility of making improvements to the database search function, which would provide more targeted data.

Draft Proposal 6

Consider whether supplying additional data compilations regarding common non-compliance issues would help improve knowledge.

Draft Proposal 7

FDA to look at ways in which social media can be utilized to better communicate its GMP compliance and enforcement efforts.

Draft Proposal 8

Context of provided data should be readily available and clearer. Making it clear to database users how often the data is updated and how reliable it is would be one example of this.

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