Drugs

Modernization of FDA Drug Regulatory Program Outlined

Attorneys Khelin Aiken and Anisa Mohanty (McDermott Will & Emery) review the FDA proposal to modernize new drug development as authorized by the 21^st Century Cures Act. The agency’s 2018 initial proposal, they write in an online post, covered:

focusing on recruiting talent across disciplines;
building multidisciplinary teams for more efficient collaboration;
prioritizing operational excellence through a single and consistent review process;
improving knowledge management through enhancements to information technology and honed expertise within review divisions;
emphasizing safety and risk-benefit analysis before and after approval; and
incorporating the patient voice into product development.

Recently, the attorneys write, FDA announced six strategic objectives that expound on the original 2018 proposal and continue throughout 2020. They are:

scientific leadership;
integrated assessment;
benefit-risk monitoring;
managing talent;
operational excellence; and
knowledge management.

The attorneys write that the agency also detailed six programs and projects currently underway that demonstrate its commitment to implementing the initiative:

a new integrated review process for drug marketing applications;
IND review management;
post-market safety management;
assessing talent;
optimizing administrative operations; and
transition management and reorganization of the new drugs regulatory program.

According to the post, sponsors and applicants can expect faster approvals, largely in part due to FDA efforts to align expert staff with their respective therapeutic areas and to retain and increase talent via the Cures Act pay authority. Sponsors and applicants also can anticipate more certainty and greater transparency in product application reviews and should anticipate the need for increased communication with FDA throughout the approval process, it says.

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