Drugs

Gillibrand Bill to Speed FDA Approval of Some Drugs

Rep. Kirsten Gillibrand (D-NY) has introduced bipartisan legislation to expedite provisional FDA approval of drugs intended to treat ALS (amyotrophic lateral sclerosis), Parkinson’s, Alzheimer’s, and other life-threatening illnesses. In a statement, Gillibrand says the standard FDA approval process takes many years to get drugs to market, and patients with rapidly progressing illnesses often don’t have many years to wait.

She says the Promising Pathway Act would accelerate the approval process by creating a “safe, accelerated approval pathway for promising drugs and make these drugs available to those who need them. Specifically, the bill would allow pharmaceutical companies to petition FDA for provisional approval of a drug that has cleared early-stage clinical trials and shown significant evidence of effectiveness. Provisional approval would make these drugs available to those whose lives depend on them while pharmaceutical companies continue to collect data and pursue full approval.”

Companion legislation is being introduced in the House, Gillibrand 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