FDA Proposes Enhancing Search Criteria for Inspections Database - Pharmaceutical Technology

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FDA Proposes Enhancing Search Criteria for Inspections Database


ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA may consider whether to add specific search criteria (e.g., those that would enable product-specific or violation-specific searches) to its inspections database to make it user-friendly and improve data analysis. The idea was included in a list of eight draft proposals for increasing transparency that the agency published on Oct. 3, 2011. FDA also proposed introducing sophisticated search capability, such as predictive name searches.

Other draft proposals in the list aim to improve data quality and facilitate timely data disclosure. The agency may consider adopting various tools, including new technologies for investigators, process improvements, or administrative incentives. These tools would be intended to expedite data entry and expedite inspection review and classification. FDA also proposed to examine how frequently data should be updated for it to be useful to stakeholders.

Another draft proposal would provide context for compliance and enforcement data to help ensure that the data are not misinterpreted or misused. The proposal document gives the following examples of appropriate contextual information:

  • Information regarding how frequently data are updated
  • Information regarding the reliability of the data
  • Information regarding the average lapse of time between an inspection and the posting of inspection-classification information
  • Definitions of inspection classification types
  • A statement explaining that the website’s lack of information regarding a particular facility does not imply compliance or noncompliance.

Other draft proposals relate to FDA’s presentation of compliance and enforcement data. For example, the agency may consider how to present the data graphically and better use mobile web applications to attract users and encourage data analysis. FDA also proposes to explore ways to better use social media, agency-sponsored webinars, and automatic email notifications to better communicate with the public.

The agency’s draft proposals are part of its response to President Obama’s Memorandum on Regulatory Compliance of Jan. 18, 2011, which requires federal agencies to make public compliance information easily accessible, downloadable, and searchable online. FDA examined the ways that the Environmental Protection Agency and the Department of Labor disclose compliance and enforcement information before creating its list of draft proposals.

FDA is soliciting public comment on the draft proposals for 60 days. Comment may be submitted at www.regulations.gov. After comments have been received, the agency’s Transparency Task Force will recommend specific draft proposals to the commissioner, who will determine whether to adopt them by Jan. 31, 2012.


See related Pharm Tech articles:

FDA Unveils Inspections Database (ePT)

FDA Considers Ways to Improve Transparency in the Supply Chain (Sourcing and Management)

FDA’s Transparency Task Force Announces Public Disclosure Proposals (ePT)

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