Drugs

Senators Introduce Bipartisan Bill on Expanded Access

U.S. Senators Michael Bennet (D-CO), Orrin Hatch (R-UT), Richard Burr (R-NC), and Bob Casey (D-PA) have introduced legislation to improve clinical trials for experimental treatments that have life-saving potential. “The current clinical trial process is outdated, preventing the FDA and drug manufacturers from developing critical treatments for patients who need them most,” Bennet said. “This legislation will provide needed direction to improve clinical trials by expanding eligibility to high-risk patients. It will also create a more streamlined and transparent process for patients who still don't qualify for a clinical trial, but need access to experimental treatments.” According to the lawmakers, the bill would:

Authorize a public meeting between FDA and NIH to discuss clinical trial criteria
Require the Government Accountability Office to study the challenges of expanding clinical trials and provide recommendations
Improve the institutional review board assessment of individual pediatric and adult patient expanded access protocols
Allow drug manufacturers and sponsors to make their expanded access policies available during Phase 1 studies, rather later Phase 2 or 3 studies, for drugs going through the breakthrough therapy, fast track product, or regenerative advanced therapy pathways.

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