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tcosgrove@cov.comContact number
+1 202 662 5260Share profile
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Provided by Tom Cosgrove
Tom Cosgrove is a partner in Covington’s Food, Drug and Device Practice Group. He joined Covington in 2017 from the Food and Drug Administration (FDA), where he was a senior official charged with ensuring the quality of drugs and therapeutic biologics marketed to U.S. patients. Tom brings a wealth of experience to bear in helping clients navigate the complex world of pharmaceutical compliance and enforcement in the United States and around the globe.
At FDA, Tom held senior leadership positions within the Office of Compliance in the Center for Drug Evaluation and Research (CDER), including leading the organization as Acting Director in 2016. Beginning in 2014, he led the Office of Manufacturing Quality (OMQ), where he was responsible for CDER’s enforcement activities covering current good manufacturing practice (CGMP) and drug quality. In this role, Tom was responsible for setting FDA’s CGMP enforcement priorities and for clearing warning letters, import alerts, and referrals for civil and criminal enforcement. He also played a central role in the FDA's deliberations concerning the approval of marketing applications submitted by companies with manufacturing compliance challenges.
Provided by Chambers
Tom Cosgrove of Covington & Burling LLP is recognized for a robust FDA regulatory practice, assisting clients with strategy, evaluation and guidance.
Provided by Chambers
Tom's relationships and judgment are extremely valuable for us. He's so strategic and good at balancing risk and benefit. He helps us be strategic and pragmatic as a result.
Tom's relationships and judgment are extremely valuable for us. He's so strategic and good at balancing risk and benefit. He helps us be strategic and pragmatic as a result.