Drugs

FDA Approves Clozapine REMS Changes

FDA approved a modification to the clozapine REMS (risk evaluation and mitigation strategy) 7/29 to become effective 11/15. An agency notice says FDA continues to work with the Clozapine Product Manufacturing Group to ensure that patients relying on clozapine have continued access to the medication and appropriate management of associated risks. The notice lists important REMS changes as:

all prescribers and pharmacies must be recertified by 11/15 or they will not be able to prescribe/dispense clozapine;
prescribers must re-enroll their patients who will continue clozapine by 11/15;
recertification and re-enrollment can begin 8/16;
pharmacies will no longer be able to use telecommunication verification (switch system) to verify safe use conditions; and
a new patient status form will document absolute neutrophil count monitoring for all outpatients on a form that must be submitted monthly.

FDA also updated its Information on Clozapine sheet with the REMS changes and a question-and-answer document.

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