Drugs

All GDUFA Obligations Being Met: Uhl

CDER Office of Generic Drugs (OGD) director Kathleen Uhl says that OGD is meeting all of its obligation under the GDUFA commitment letter. In a 2/23 slide presentation to the Generic Pharmaceutical Association annual meeting, she said that OGD is “going above and beyond the commitments” and building a modern, 21^st century, generic drug program. The result of this work, she says, has been a significant and sustained increase in communications, actions, and approvals.

The presentation says that actions and approvals/temporary approvals are all up, as is communications. For the first quarter of the current fiscal year, it says, there were 190 approvals, 48 tentative approvals, and 310 complete responses. December of 2015 saw the highest number of approvals and tentative approvals in one month, 99, she said. And calendar year 2015’s approvals and tentative approvals was the highest ever at more than 700.

The presentation covered output and productivity, quality of ANDA submissions, an update on the pre-year 3 cohort, and opportunities for improvement and challenges.

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