Biologics

Cell, Gene Therapy Application Backlog Questioned

Reps. Brett Guthrie (R-KY) and Anna Eshoo (D-CA), the chair and ranking member of the House Energy and Commerce Committee’s Health Subcommittee, have written to CBER director Peter Marks expressing concern about an increase in the number of clinical holds on BLAs for cell and gene therapies. They ask Marks to explain FDA’s process for addressing the holds.

The letter says that while Guthrie and Eshoo recognize that clinical holds are an important regulatory tool, “they should be used judiciously and appropriately. CBER should not, for example, use clinical holds as a means for FDA to gain additional time to review a clinical protocol…. We are concerned, after hearing from researchers and patients, that CBER seems to be applying holds on some cell and gene therapies for issues that could possibly be resolved through discussions with sponsors without an issuance of a clinical hold.”

The letter asks for responses to seven detailed questions involving the number of clinical holds, the reasons for the holds, the speed with which holds are removed, PDUFA 7 commitments, and new CBER staff to assist with cell and gene therapy review.

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