FDA Policy/General

Pilot Considered on Evaluating Novel Excipients

Federal Register notice: FDA has established a docket to obtain information and comments that will assist it in determining whether to establish a pilot program for the toxicological and quality evaluation of novel excipients intended for use in human drugs. Historically, FDA has not reviewed the safety of novel excipients outside the context of an IND, NDA or BLA describing a finished product to which the excipient has been added. Stakeholders have encouraged FDA to establish such a program for submitting and reviewing toxicological and quality data supporting the use of novel excipients in drug products outside the context of an IND, an NDA, or a BLA. Proponents of an FDA novel excipient review program believe FDA's recognition of a novel excipient would reassure drug developers that the novel excipient can be used in a drug development program while minimizing the risk that safety concerns would be raised by FDA during application review. They have also cited a perceived risk aversion on the part of drug developers, such that novel excipients may be avoided in drug development programs, even when the excipients have potential public health benefits. To view the notice, click here.

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

Read more

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