FDA Policy/General

Regulatory Science Drives Product Innovation: Ostroff

FDA acting commissioner Stephen Ostroff says FDA’s focus on regulatory science is helping drive innovation and speed the discovery, development, and delivery of medical products to prevent and cure disease and improve health. Writing a mid-December year-end review FDA Voice blog post, Ostroff looked at the agency’s role in “making safe, effective, and innovative products available to patients who need them.”

He recalled the FDA Independent Science Board 9/2015 report documenting the agency’s progress and transformation over the last eight years to the point that today “FDA’s regulatory science enterprise is much stronger, which better allows us to effectively fulfill our commitment to protect the public health.”

So far in 2015, Ostroff wrote, the agency has approved more than 40 novel drugs, including four new treatments for patients with multiple myeloma, two drugs for patients with heart failure, and several drugs for orphan diseases. The agency also approved several important vaccines and several innovative medical devices.

“The U.S. continues to lead the world in approving novel drugs first,” Ostroff said. “And we’ve seen important progress in our device review program. Our average time to reach decisions on PMAs has dropped 36% since 2009. And not since 2001 has FDA approved as many medical devices under the original premarket approval pathway and the panel track supplement pathway as we did this year — 58 as of 12/14.”

His year-end review also highlighted the Patient-Focused Drug Development initiative, Patient Engagement Advisory Committee, guidances on the approved pathway for biosimilars, the precision medicine initiative, and refining critical trial design and statistical methods of analysis to create more efficient studies with smaller patient populations, more focused therapies, and better outcomes.

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