FDA Policy/General

Hogan Lovells Hires Former FDA Investigator

Law firm Hogan Lovells has added former FDA investigator Chris Middendorf as the firm’s regulatory affairs director. In this capacity, Middendorf will assist life sciences clients with regulatory and policy issues, such as product quality and manufacturing issues, and related compliance with FDA requirements for pharmaceuticals and biological products.

During his 20-year tenure at FDA, Middendorf conducted GMP domestic and international inspections while developing scientific and technical expertise in sterile manufacturing and data integrity, according to the law firm. He held senior positions for regulatory activities in China and India.

His agency tenure included senior positions with country-wide responsibilities for China and then India, each with diplomatic status, and serving as senior policy advisor and aseptic manufacturing “subject matter expert” for the Office of Manufacturing Quality, within the Office of Compliance of FDA’s Center for Drug Evaluation and Research.

At Hogan Lovells, Middendorf will give companies “practical advice on day-to-day compliance issues and broader strategic matters, helping companies prepare for FDA inspections and respond to agency observations,” the law firm says. “He also will be a key member of the Hogan Lovells team providing detailed due diligence for life sciences transactions.”

Middendorf has a bachelor’s degree in biology from the University of Cincinnati, and a master’s degree in animal science from Auburn University.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome