Drugs

Harpreet Singh Leaves FDA for Precision Medicine

After a nine-year career at FDA, Oncology Drugs Division director Harpreet Singh has left the agency to join Precision for Medicine as chief medical officer, responsible for medical strategy and oversight.

“The wealth of experience that Dr. Singh brings to Precision from over a decade of experience at the FDA and National Cancer Institute will be invaluable to our organization, our clients and, ultimately, patients,” the group says in a release. “She is a proven leader in precision medicine, novel trial design and innovative regulatory initiatives designed to expedite clinical development.”

At FDA, Singh oversaw the division that regulated drugs and biologics for treating thoracic and head and neck malignancies, neurologic tumors, pediatric solid tumors and rare tumors. She also managed the agency’s Project Pragmatica, a program to streamline clinical trial procedures and enhance patient centricity by integrating aspects of trials with real-world routine clinical practice and pragmatic design elements.

Singh received her medical degree from the University of Southern California (USC). She completed her internal medicine residency and Geriatrics fellowship at USC, followed by a medical oncology fellowship at the National Cancer Institute.

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