Drugs

Praise for Pediatric Study Plan Guidance Revision

Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization say they share FDA’s goal of ensuring adequate study of and labeling for use of drug and biological products in children. In a comment to an agency draft guidance on the content and process for submitting initial pediatric study plans and amended plans, the two groups commend FDA for revising a 2013 draft guidance by incorporating stakeholder feedback and reissuing the draft guidance for further comment. The two groups also submit specific comments on various sections of the draft.

In its comment, Novo Nordisk says the revised guidance “provides helpful clarifications regarding provisions in the 2013 draft guidance, an updated Study Plan Template, and several new sections. These changes have added to the overall quality of the guidance and will facilitate alignment between the sponsor and FDA.”

Similar praise for FDA’s incorporation of public comments leading to changes in the guidance comes from Pfizer in its comment letter.

A response from the International Consortium for Innovation and Quality in Pharmaceutical Development notes that very limited guidance is provided on how to effectively align the initial pediatric study plan with the European Union’s counterpart plan.

Finally, specific line-by-line comments were submitted by Quintiles and Regeneron.

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