Cathy Burgess is quoted on how the U.S. Food and Drug Administration may relax its stance on re-inspection of facilities receiving Official Action Indicated notices due to the coronavirus pandemic.
In the News
July 1, 2020
The Pink Sheet | US FDA Invites Warning Letter Follow-Up Inspection Alternative Proposals as Pandemic Persists
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Advisories June 14, 2022FDA/Food, Drug & Device / Health Care Legislative & Public Policy Advisory: Food and Drug Amendments of 2022 (PDUFA VII)Our FDA and Health Care Policy teams discuss how sponsors and manufacturers can prepare for legislative and regulatory changes that could come from the final Food and Drug Amendments (PDUFA VII) and what companies can do today to leverage their current capabilities for success.
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Medical Products Supply Chain Week in Review April 26, 2021COVID-19 Medical Products Supply Chain Week in Review – April 26, 2021President Biden announced exceeding 200 million COVID-19 vaccine shots. The FDA and CDC decided to resume the use of J&J’s vaccine, and the FDA finished its inspection of the Emergent Baltimore site with nine observations. Read the details in the COVID-19 Medical Products Supply Chain Week in Review.
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In the News March 1, 2021The Pink Sheet | Drug Manufacturers Beg US FDA to Inspect Facilities, but Still Find DifficultiesCathy Burgess is quoted on COVID-19 safety considerations for Food and Drug Administration inspections.
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In the News January 5, 2021Inside Health Policy | FDA Inspection Plans Unclear as EUAs Move toward Full ApprovalsCathy Burgess is quoted on how the Food and Drug Administration might conduct remote inspections of drug manufacturing facilities amid COVID-19.
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In the News October 28, 2020The Pink Sheet | COVID-19 Vaccines: FDA’s Broad Authority to Craft Narrow EUAs May Push Agency Out of Its Comfort ZoneCathy Burgess is quoted on the potential impact of the U.S. Food and Drug Administration’s plan to tailor an emergency use authorization to a COVID-19 vaccine.