Drugs

Facilitating Surrogate Endpoints in Drug Development

CDER biomarker development and regulatory science team science policy analyst Abena Agyemanm says FDA is making available additional resources for drug development programs that want to use surrogate endpoints. She says one such resource is the Table of Surrogate Endpoints That Were the Basis of Drug Approval or Licensure for both traditional and accelerated approval.

“The table lists the surrogate endpoints FDA has accepted or could accept as primary efficacy endpoints in drug development programs,” she says. “In addition, FDA is also accepting Type C IND meeting requests focused on potential novel surrogate endpoints that may be used in drug development programs.”

Agyemanm’s small business assistance post says that when a surrogate endpoint clearly predicts a beneficial effect through appropriate studies, its use generally allows for more efficient drug development programs. She says the use of surrogate endpoints for certain clinical studies has helped to expedite drug development. “As science and technology advance,” she concludes, “increased use of biomarkers and surrogate endpoints will hopefully facilitate the more efficient development of safe and effective medical products.” FDA will receive comments and suggestions on publication of the surrogate endpoints table until 12/31.

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