Drugs

Platform Technology Designation Guidance

FDA has published a draft guidance, Platform Technology Designation Program for Drug Development, with details about the implementation of the platform technology designation program that was enacted as part of the 2023 Consolidated Appropriations Act. The agency says the document outlines eligibility factors for receiving a platform technology designation, how to leverage data from designated platform technologies, how to discuss a planned designation as part of a milestone meeting, the recommended content of a designation request submission, and the review timelines for a designation request.

The agency says the guidance outlines how a well-understood and reproducible technology in an FDA-approved drug or biological product may be eligible for a platform technology designation. "There are several potential benefits for a drug company that receives a platform technology designation, including having early and additional interactions with FDA to discuss the use of a platform technology and leveraging information previously submitted in support of the designation in subsequent submissions from the same sponsor, such as new drug or biologics license applications," it says.

“This program is intended to result in efficiencies in drug development, manufacturing, and review processes for drug product applications that incorporate designated platform technologies,” the draft 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

Read more

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