Drugs

New Approach to IVIVC Needed in NDAs: FDAers

Four CDER staffers say that the drug industry, academia, and regulatory agencies need to make a collaborative effort to develop new approaches and technologies for in vivo in vitro correlations (IVIVC) so they can be better used in drug development and post-approval manufacturing changes. Writing in the AAPS Journal, published by the American Association of Pharmaceutical Scientists, the four say that in the past two decades, IVIVC has been considered an important tool for supporting biowaivers, setting dissolution acceptance criteria, and in the quality by design framework to promote establishment of clinically meaningful drug product specifications using dissolution as the endpoint.

Based on their FDA review experience, the four say that the overall acceptance rate of IVIVC submissions in the past decade has been 40%. And the number of IVIVC studies seen in the submissions per year has not increased.

“Establishing clinically meaningful drug product specifications through the linkages between the identified critical quality attributes and in vivo performance is key for developing a quality drug product,” the article says. “To achieve this goal, there is an imminent need for addressing the issues behind a low success rate in IVIVC development.”

Special considerations should be taken, the authors say, in areas such as (1) selection of appropriate number/kind of formulations for IVIVC development/validation; (2) construction of exploratory plots to guide model building and selection; (3) investigation of the reasons of inclusive predictability; (4) improvement in the quality and richness of the data; and (5) avoidance of over-parameterization.

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