Drugs

FDA on Schedule with Sunscreen Innovation Act: GAO

The Government Accountability Office (GAO) says FDA implemented requirements for reviewing applications for sunscreen active ingredients within time frames set by the 2014 Sunscreen Innovation Act. The act contained a provision for GAO to examine FDA’s implementation. As an example of meeting time frames, GAO says FDA issued an 11/2016 guidance on safety and effectiveness testing.

The act was approved because some sunscreen manufacturers with active ingredients marketed elsewhere but not in the U.S. wanted to have the ingredients added to the FDA sunscreen monograph.

GAO says that as of August, all applications for sunscreen active ingredients remain pending because FDA determined that it needed additional safety and effectiveness data on them to complete its review. Sponsors of the some of the applications and some stakeholders have questioned the agency’s data requests, GAO says, while other stakeholders back the additional testing it has requested.

None of the sponsors reported current plans to provide the requested information. GAO says it learned they either are still considering the FDA request or have decided not to proceed due to the likely return on investment, agency rejection of sponsor proposals for alternate forms of testing, and concern about the agency’s request for animal testing.

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