Drugs

Environmentalists Want Sunscreen Evaluation

The Environmental Working Group is asking FDA to investigate whether ingredients and other technologies are being used to boost sunnscreen SPF claims by masking the skin reddening that the group says is the body’s warning sign of skin damage. An 8/18 letter says that such products “may encourage people to remain in the sun where, though they don’t see or sense burning, they may in fact sustain subtle or profound damage to the skin, potentially leading to cancer.”

The national environmental health organization calls on the agency to:

investigate the use of anti-inflammatories, antioxidants, and other ingredients in sunscreen products that may increase SPF measurements without shielding the body from UV light, as well as the correlation, if any, between protection from skin reddening, immunosuppression, long-term skin damage, and cancer;
finalize its proposed 2011 rule that would cap SPF values at 50+; and
require companies to display the lower value obtained from measuring the sun protection factor in vitro and in vivo when determining the SPF of products.

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