Drugs

PhRMA’s 4 Open FDARA Implementation Issues

Pharmaceutical Research and Manufacturers of America (PhRMA) says there are four key, open FDA Reauthorization Act (FDARA) implementation issues that FDA should address. In its comment letter submitted to the docket for the Pediatric Oncology Subcommittee 5/22 meeting to discuss perspectives relating to implementation of FDARA, PhRMA identifies the issues as:

clarifying the evidentiary standard that it applies to determine if a molecular target is “substantially relevant” to the growth or progression of a pediatric cancer;
confirming that an applicant may submit, but is not obligated to generate, nonclinical data to inform a substantial relevance determination;
establishing a time-bound process for deciding whether the molecularly targeted pediatric cancer investigation requirement applies to an application; and
confirming the inapplicability of the traditional Pediatric Research Equity Act assessment requirement to an orphan-designated indication for which the molecularly targeted pediatric investigation requirement does not apply.

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