Comparison of content of FDA letters not approving applications for new drugs and associated public announcements from sponsors: cross sectional study -

Comparison of content of FDA letters not approving applications for new drugs and associated public announcements from sponsors: cross sectional study
Information type: Other primary research
Source: British Medical Journal
Specialities:
Summary
Study found in many cases, press releases were not issued in response to letters from FDA to drug companies rejecting their marketing applications, and, when they were, they omitted most of statements in the letters, which usually related to safety and/or efficacy deficiencies.
UKMi comment
An editorial notes that “although hampered by lack of disclosure of specific product and manufacturer names, this study is a welcome first step by regulators towards analysing and publishing data about discrepancies between the information they have available in pre-market and post-market submissions and reports that are in the public domain. Such engagement is welcome, must continue, and could contribute substantially to the quality and accuracy of information available to doctors and patients on the benefits and harms of medicines.”
Related links: Editorial