Drugs

New Guidance on Benefit-Risk Evaluation Reports

FDA has posted a revised International Council on Harmonization (ICH) guidance entitled “E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER)” that defines the recommended format and content of such reports and offers points to be considered in preparing and submitting them. The guidance revises, combines, and replaces two ICH guidances — E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs and Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs.

A formal evaluation of a drug’s benefit is a new feature of the PBRER, the agency notes, and it is “recognized that a concise discussion of benefit will usually be sufficient, unless the safety or benefit-risk profile has changed significantly during the reporting interval. Thus, the level of detail provided in certain sections of the PBRER (e.g., evaluation of safety and efficacy data, evaluation of safety signals, and benefit-risk evaluation) should be proportional to the medicinal product’s known or emerging important risks and to evidence of emerging important benefits.”

Additionally, FDA has posted a companion question and answer guidance entitled “E2C(R2) Periodic Benefit-Risk Evaluation Report: Questions and Answers” to support the PBRER guidance’s implementation. It is intended to facilitate practical implementation of the PBRER, including points to consider in addressing some of the more novel aspects of the new periodic safety report, according to the agency.

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