Cathy Burgess is quoted on recent guidance by the U.S. Food and Drug Administration that could include virtual inspections of manufacturing sites amid COVID-19 and how the industry should continue urging the FDA to adopt these new approaches.
In the News
August 25, 2020
Pink Sheet | What the FDA’s Inspections Q&A Guidance Really Means: It’s Time to Offer Virtual Inspections
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In the News April 23, 2020Politico | How a Lack of FDA Inspections Will Likely Lead to Drug RejectionsCathy Burgess comments on the U.S. Food and Drug Administration’s approach to approving drug applications amid COVID-19.
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Press Release January 28, 2022Alston & Bird Adds Former FDA Associate Chief Counsel Alexandra Marzelli as Counsel in Washington, D.C.Alston & Bird has expanded its health care and life sciences regulatory and compliance capabilities with the addition of counsel Alexandra Marzelli, former associate chief counsel at the U.S. Food and Drug Administration (FDA). Based in the firm’s Washington, D.C. office, Marzelli joins Alston & Bird’s Health Care and FDA/Food, Drug & Device Groups, where she will advise clients on the FDA’s complex approval process and regulatory compliance for prescription and over-the-counter drugs, biologics, medical devices, food ingredients, and other products regulated by the agency.
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Medical Products Supply Chain Week in Review May 18, 2021COVID-19 Medical Products Supply Chain Week in Review – May 18, 2021The FDA authorized the Pfizer COVID-19 vaccine for adolescent use and updated its inspection guidance again. In addition, President Biden announced reaching the 250 million vaccine shot milestone. Read the details in the COVID-19 Medical Products Supply Chain Week in Review.
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In the News March 11, 2021Law360 | The Defining Pandemic Moments for Health and Life Sci AttysCathy Burgess is quoted on the dramatic decline in the Food and Drug Administration’s foreign inspections amid COVID-19.
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Press Release March 9, 2021Cathy Burgess Honored as a 2021 “Health Care | Life Science Trailblazer” by The National Law JournalCathy Burgess, partner in Alston & Bird’s Health Care Group and leader of the firm’s FDA Compliance & Enforcement Team, has been recognized by The National Law Journal in its third annual list of professionals identified as agents of change in health care and life sciences law.
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