Drugs

OGD Conducting Regulatory Research in 18 Topics

CDER Office of Generic Drugs (OGD) director Kathleen Uhl says that during GDUFA 1 her Office of Research and Standards “built an extensive research portfolio to support development of new methodologies and tools to help establish equivalence standards.” In a report, Uhl says that between 2013 and 2017 OGD awarded 36 research contracts and 69 grants for innovative research projects on generics. She says the contracts and grants resulted in significant accomplishments, from developing the scientific basis to support new and revised guidances for industry to refining methods for evaluating generic drug products.

According to Uhl, the research activities are divided into 18 topic areas. “We have chosen several high-profile topic areas on which to provide an in-depth look of the progress made since the start of GDUFA,” she says. “The results from the first five years of the GDUFA regulatory science program illustrate the significant strides OGD made in addressing questions about therapeutic equivalence and the scientific evaluation of generic drug products.”

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