FDA Policy/General

FDA Should Adapt to New Technology Areas: Gottlieb

FDA should adapt how it approaches pre-market regulation in order to properly address very novel areas of technology like gene editing and cell and gene therapy, according to former deputy commissioner Scott Gottlieb. His remarks were made this week at the International Society for Stem Cell Research in Berkeley, CA.

The bottom line, according to Gottlieb, is that the agency needs to “more closely focus is organizational structure and its regulatory programs on measures of risk, and move away from its structural legacy that oriented its review programs mostly around discrete clinical areas of medicine. More and more, it’s the product features of these novel technologies, and not necessarily their clinical applications, that create the hypothetical and known risks. The regulatory efforts need to be structured around these product areas. That means FDA needs to organize more of its regulatory activities around programs centered on areas such as regenerative medicine and gene editing. It needs to more closely adjust its regulatory approach to address the unique nature of the different risks that it’s trying to address.”

Gottlieb also said FDA needs to focus on “those areas that create the most potential for risk, and channel its resources behind these efforts. It needs to be much more risk based. Right now, FDA is often too easily distracted by attractive areas like iPhone apps that nonetheless pose relatively low risks and could be ably addressed by other regulatory agencies.”

Gottlieb’s full remarks are reprinted on Forbes.com.

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