Drugs

OGD Reports Record Generic Approvals Last Year

Last year, CDER’s Office of Generic Drugs (OGD) approved the highest number of ANDAs in the history of the generic drug program – more than 800 submissions (including full and tentative approvals). Last year’s performance eclipsed 2015’s previous record of 726 ANDAs.

In a new blog posting, OGD director Kathleen Uhl attributed the record performance to resources provided under the Generic Drug User Fee Amendments (GDUFA) of 2012. “With the assistance of many other offices throughout FDA, OGD is on track to meet, or has already met, all of our GDUFA commitments,” Uhl said. “In addition to increased approvals and tentative approvals, FDA improved communications processes to alert industry to deficiencies in their applications, which reduces the number of review cycles and supports faster approvals.”

OGD is also making a significant effort to spur generic drug development. “For example, GDUFA Regulatory Science priorities contribute valuable research to generic drug development,” Uhl said. “Our efforts are geared to helping the generic drug industry develop validated scientific methods for demonstrating bioequivalence and assuring therapeutic equivalence to the brand-name counterpart. We are translating the results of these scientific efforts into generic drug product development via recommendations for specific drug products, which assist the generic drug industry during product development.”

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