FDA Policy/General

FDA Enterprise Modernization Plan Explained

FDA principal deputy commissioner Janet Woodcock says FDA is working toward new efficiencies through an agency-wide enterprise approach to its business process, data, and technology management that will allow it to work more efficiently and optimize the use of the vast amount of data that is the foundation of its work. Writing in an FDA Voices post, Woodcock and senior medical advisor Meredith Chuk describe the Enterprise Modernization Action Plan (EMAP) that follows 2019’s Technology Modernization Action Plan and the 2021 Data Modernization Action Plan.

“Our IT and data modernization efforts form a strong foundation for the future and will continue to evolve,” they write. “Changes at the data and technology levels must be accompanied by improved business operations to achieve our goals. The EMAP describes our plans to shape FDA’s future by delivering successful cross-agency efforts that optimize common and essential business processes. We will do this work methodically, ensuring we are solving the right problems, with the right team, to produce measurable results.”

Woodcock and Chuk identify the three components of the EMAP as:

creating the infrastructure to support change;
developing a common operational approach; and
ensuring strategic alignment.

“Successful enterprise transformation will ensure that FDA functions not as a collection of Centers and Offices but as an integrated agency, getting the most from our talent, technology, and budget,” the two conclude. “This transformation will be a continual and incremental journey, supported by a change mindset at all levels of FDA to break down barriers, eliminate silos, and optimize our work.”

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