Where does my prescription come from? Has it been altered or diluted? Can I trust the label? With millions of prescriptions filled each year, quality control and security across the pharmaceutical supply chain seems like a herculean task. In an attempt to slay this proverbial hydra, the Food and Drug Administration (FDA) developed a new pilot program – the DSCSA Blockchain Interoperability Pilot (the “Blockchain Pilot”) – which aims to use blockchain to create a secure electronic, interoperable system that tracks and traces certain prescription drugs as they are distributed in the United States.
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Medical Devices – Artificial Intelligence and Reactions to FDA’s Proposed Oversight
By Sheppard Mullin on
Posted in FDA, Medical Devices
Originally posted on the Sheppard Mullin FDA Blog on June 25, 2019.
In April of this year, the US Food and Drug Administration (FDA) released a discussion paper, Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML) – Based Software as a Medical Device (SaMD), which proposed a novel regulatory framework for artificial intelligence (AI)-based medical devices. The public docket closed on June 3, 2019, and FDA received over one hundred comments from manufacturers, industry associations, and other interested parties. The comments vary in support of FDA’s framework and largely urge FDA to align with external stakeholders that are already developing industry standards and clarify the agency’s expectations under the proposed framework.
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FDA Issues Warning Letter to Lab Marketing Three Laboratory-Developed Tests
By Kenneth Yood on
Posted in FDA
In an April 4, 2019 Press Release, the U.S. Food and Drug Administration (FDA) announced its issuance of a Warning Letter to Inova Genomics Laboratory (Inova) in Virginia for marketing genetic tests for predicting medication response and patient receptivity to drugs (among other things). FDA identified three genetic tests, including one called “MediMap Plus,” which was designed to provide insight into how a patient would respond to drugs used for anesthesia, cancers, infections, attention-deficit/hyperactivity disorder, depression, anxiety, and diabetes. FDA deemed the tests to be adulterated and misbranded because Inova had not sought premarket clearance.
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