Drugs

CDER’s Clin/Pharm Office Outlines Priorities

CDER’s Office of Clinical Pharmacology (OCP) says that in 2019 it will focus on current health issues related to the opioid epidemic, antimicrobial resistance, and rare diseases. In its latest annual report, OCP says the application of pharmacogenomic information will continue to play an important role in clinical trial design and therapeutic optimization. “Our office will continue to facilitate and support the advancement of biosimilar development under the reauthorized user fee programs and continue to lead the advancement of [model-informed drug development (MIDD)] approaches in drug development under PDUFA VI,” the report says.

OCP also expects to review more MIDD-related drug applications and plans to host a series of MIDD workshops and educational events in the coming year. “OCP commits to bringing consistency and transparency to new policy areas (e.g., MIDD and lifecycle management), and additional policy efforts will be informed through proactive and expanded engagement with external stakeholders on emerging scientific and regulatory issues,” the report says.

“Our review teams, research scientists, guidance and policy experts, communication specialists, and project/program management staff will continue to work synergistically to advance translational science, identify and inform policy gaps, and strengthen approaches in drug development and regulatory practice,” it says.

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