Drugs

FDA, EMA Early Access Approach Report

FDA and the European Medicines Agency have published a report on their 11/26/18 workshop with stakeholders on support for quality development in early access approaches such as PRIME (priority medicines) and Breakthrough Therapy designation. “Experience to date has shown that applicants face challenges to complete quality and manufacturing development and data requirements during development of products in early access approaches,” the report says. “In order to address and overcome these challenges, U.S. and EU regulators wish to support applicants with guidance and risk-based flexibility regarding their pharmaceutical development program including, for example, product characterization, specification setting, validation and stability testing as well as early identification of quality issues/attributes that are critical to the clinical use of the medicinal product.”

The workshop’s aim was to discuss between regulators and industry the quality challenges and possible scientific and regulatory approaches that could be used to facilitate development and preparation of robust data quality packages, to enable timely access to medicines for patients while providing assurance that patient safety, efficacy, and product quality are not compromised.

Sessions discussed in the report were background and scope of early access approaches; process validation; control strategy; GMP compliance; breakout session on biologicals process validation and control strategy, comparability and stability; breakout session on chemicals control strategy and stability; regulatory tools to support early access; and general discussion to sum up and point a way forward.

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