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November 18, 2020
Health Law Daily

GAO Says FDA Has Been Inconsistent With Data Disclosures For Authorized COVID-19 Products

  • November 18, 2020

Bloomberg Law (11/17, Lee, Subscription Publication) reports behind a paywall “the FDA hasn’t been consistent with the safety and efficacy data it’s disclosed for authorized [COVID-19] products and needs to beef up transparency with providers and the public...said” the Government Accountability Office (GAO). The GAO’s “recommendations are aimed at improving public trust in the Food and Drug Administration during a time of wavering confidence in federal institutions’ ability to handle the pandemic.” The agency “authorized several virus therapies, ‘but the evidence to support its authorization decisions was not always transparent,’ the GAO said in a new report.”