Drugs

Extend Drug Review Gains to More Areas: CLSA

The California Life Sciences Association (CLSA) says that FDA’s success in improving overall drug review times and processes is to be applauded, and the next round of user fee negotiations can be used to replicate the improvements across all therapeutic areas. In a CLSA Wire report, the association says that overall FDA performance has improved markedly in terms of ensuring timely and efficient drug review processes while maintaining rigorous scientific and safety standards.

The association says the improvements are a reflection of the work by FDA leadership, industry, Congress, and other stakeholders. And it says that refinements such as the 2012 FDA Safety and Innovation Act and the breakthrough therapy mechanism have accelerated approvals.

“Still,” it says, “there are wide variations across therapeutic areas, with some indications, such as oncology and infectious disease, benefitting more than others. As we approach the next user fee reauthorization and recognize the differences across therapeutic areas, there is a real opportunity to identify managerial, procedural, and other practices that will promote more consistency across the agency.”

The report shows that despite decreases in average approval times, endocrine, gastrointestinal, and central nervous system therapies have lagged behind in recent years.

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