Drugs

Allergan Wants More Changes in Cyclosporine Guidance

Allergan says that a revised FDA draft guidance on cyclosporine has improved, in certain important aspects, the scientific rigor of analyses suggested in the earlier version, but still leaves open some “fundamental gaps that prevent the 2016 draft guidance from describing in vitro analyses that could be adequate on their own to allow FDA to judge whether a proposed generic cyclosporine ophthalmic emulsion is bioequivalent to Restasis.” The firm’s 4/18 comment letter says the revised draft does not address the basic problem with relying on in vitro analyses to establish bioequivalence to Restasis, which is that to date no in vitro analyses for the product have been validated as a proxy for in vivo bioavailability.

The letter asks that the agency address in vitro release method, methodology to assess globule sizes, drug distribution in different phases of the emulsion, the lack of stated ranges for other analytical parameters, evaluation of multiple products and replicates, and the notion that non-biological complex drugs require more thorough analysis to evaluate bioequivalence.

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