Drugs

OGD on Track to Meet all GDUFA Goals: Uhl

CDER Office of Generic Drugs (OGD) director Kathleen Uhl says that the office is on track to meet the goals set for it under the 2012 Generic Drug User Fee Act (GDUFA). Writing in an FDA Voice blog post, Uhl says that 2015 was the first full year of operation after vast expansion of the OGD scope and structure. “This change allowed for the office to have greater prominence and allowed for additional staff to handle a growing workload and enhance our ability to advance the safety and availability of generic drugs in the U.S.,” she writes.

As part of her blog post, Uhl announced release of the first OGD annual report. She said it is “filled with detailed accounts of our work, which seeks to improve the generic drug program with more efficient reviews of applications, and by developing the science needed to help the generic drug industry demonstrate that their products are as safe and effective as their brand-name counterparts.”

In 2015, Uhl writes, OGD had the highest number of generic drug approvals and tentative approvals ever awarded by FDA, more than 700 total. And in 12/2015, she says, the office granted the highest number of approvals and tentative approvals in a single month (99) since the generic drug program began.

Responding to a GDUFA commitment to take first action on 90% of backlog applications by 2017, Uhl says that by the end of 2015, first actions were completed on 84% of ANDAs and 88% of prior approval supplements. In addition, 90 first generics were approved.

“Despite our progress, we have a lot more work to do,” Uhl concludes. “But we don’t expect to do it entirely on our own. Achieving goals that work for the public requires input from the public, including industry, the research community, lawmakers and other stakeholders. As part of our effort to align with stakeholders’ visions, we’re holding a public meeting on 5/20 to solicit valuable feedback on our regulatory science initiatives and help us chart directions forward.”

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