FDA Policy/General

Watch FDA’s Social Media Reg. Changes: Lawyers

Attorneys Sheila Boston and Candice Andalia (Kaye Scholer) say that drug and medical device companies should closely follow the evolving FDA regulatory landscape affecting company use of social media. Writing in an online blog post, they review the agency’s regulatory actions taken through Warning Letters, untitled letters, and draft guidances, and then make recommendations. “Without detailed regulations or finalized guidance, the scope of FDA’s nascent Internet and social media policies is unclear and leaves open many questions for the pharmaceutical and medical device industry,” the two write.

Their recommendations include:
designing flexible social media policies that can change in response to additional guidance and/or regulations; integrating social media policies into contracts with agents and celebrity spokespersons to ensure that messages etc. comply with FDA restrictions and recommended submission methods; putting in place mechanisms for tracking Web sites and platforms on which employees, agents, and spokespersons post messages or statements about regulated products; limiting social media to disseminating non-promotional information and/or neutral scientific medical information only; and limiting social media advertising to those drugs, biologics, and medical devices that have few risks and clearly defined patient populations.

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