Drugs

Bill to Streamline Generic Drug Approvals

Sens. Maggie Hassan (D-NH) and Rand Paul (R-KY) have introduced legislation (S. 4338) they say will streamline the process for approving generic drugs. A statement says companion legislation was introduced in the House by Rep. Annie Kuster (D-NH) earlier this year.

Hassan says the bill would require FDA to more clearly identify the specific differences between a generic and a branded drug, thereby streamlining the approval process. Currently, she says, the agency requires generic drug manufacturers to demonstrate that they have the same active and inactive ingredients in the same concentration as the reference-listed drug. However, she says, when a generic drug contains the wrong amount of inactive ingredient, FDA cannot disclose the exact error, forcing manufacturers to engage in an “often lengthy guessing game to reach the right balance.”

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