Drugs

CDER Posts Revised Policy on Good Review Practices

CDER has posted a revised Manual of Policies And Procedures (MaPP) on the publication and use of good review practices (GRPs) within the Center. “Review staff are expected to become thoroughly familiar with pertinent GRPs and to adhere to these GRPs when conducting their reviews unless a particular part of a GRP is not applicable to a particular review or the review staff receive supervisory instruction to do otherwise,” the MaPP says. “The approving supervisor should separately document his or her reason for such a deviation in the electronic or paper document archive associated with that application. Team leaders and supervisors are required to ensure that review staff follow GRPs.” All GRPs will be maintained on the GRP Web page at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ucm118777.htm.

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