Drugs

Bill to Expedite Opioid Alternative Approval

A bipartisan group of four senators has introduced legislation they say will help bring non-opioid or non-addictive pain medications and treatments for substance abuse disorders to patients more quickly. The bill was introduced by Sens. Orrin Hatch (R-UT), Michael Bennet (D-CO), Joe Donnelly (D-IN) and Todd Young (R-IN), and instructs FDA to issue guidance to clarify the qualification parameters for breakthrough designation and accelerated approval and how they apply to novel non-opioid or non-addictive pain medications and treatments for substance abuse disorders.

In a statement, the senators say that the 2012 Advancing Breakthrough Therapies for Patients Act created a safe pathway for FDA to expedite approval for treatments that show dramatic responses in early development. And, it says, the accelerated approval program allows earlier approval of drugs that treat serious medical conditions and fulfill an unmet need.

“While these approvals are regularly granted,” the statement says, “there is currently a lack of clarity surrounding the approval process for alternatives to opioids and treatments for addiction. The bipartisan bill introduced today (4/16) clarifies this process to bring novel, non-addictive drugs and treatments to market more quickly.”

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