Drugs

Novel Excipient Review Program Comments

AstraZeneca says it welcomes an FDA proposal for a novel excipient review program as it could “significantly de-risk the introduction of novel excipients into formulations for new marketed products and hence improve patient access to potentially life-enhancing medicines, as well as to encourage the use of a wider range of excipients.” The company comment letter also includes line-by-line specific comments.

The International Pharmaceutical Excipients Council of the Americas says it strongly supports establishing a pilot program for evaluating the toxicology and quality of novel excipients intended for use in human drugs. The council says it believes that such a review program would encourage early development and use of novel excipients to facilitate advancing the next generation of medicines to patients and help stimulate excipient innovation in the global pharmaceutical industry.

Finally, the U.S. Pharmacopeia comments that establishing new pathways for development and regulatory review of novel excipients “is critical in facilitating innovation for the advancement of new medical products.” It recommends using the Global Substances Registration System to promote consistency of the official names for novel excipients evaluated by FDA.

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