Drugs

New FDA KASA System Explained

The new FDA Knowledge-aided Assessment & Structured Application (KASA) system “will promote issued-based quality assessment using structured data and information to improve the efficiency, consistency, and objectivity of regulatory actions,” according to six CDER staffers writing in the International Journal of Pharmaceutics. The article says the agency recognized the need for internal change in response to increasing expectations from the pharmaceutical industry, public demands, and technological advancements to keep pace in the 21^st century.

The new system is designed to:

capture and manage knowledge during the lifecycle of a drug product;
establish rules and algorithms for risk assessment, control, and communication;
perform computer-aided analyses of applications to compare regulatory standards and quality risks across applications and facilities; and
provide a structured assessment that minimizes text-based narratives and summarization of provided information.

The authors say the KASA system “moves regulatory application assessment from the current unstructured text document to an issue-based regulatory and technical assessment using structured data and information with standard formatting, a common vocabulary, and a uniform output. In turn, this improves consistency, transparency, communication, and objectivity of regulatory actions, as well as knowledge management within the agency.”

When fully developed and implemented, they conclude, KASA will contribute to:

assuring patient-focused quality standards and the objectivity of regulatory actions through knowledge management;
enhancing science- and risk-based regulatory approaches through established rules and algorithms; and
enriching regulatory oversight through lifecycle management of products and facilities.

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