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Allison Fulton is a partner in the Life Sciences and FDA team and is based in the firm's Washington, D.C. office.

According to a recent study (Study) published in Nature Reviews Drug Discovery on May 10, 2020 regarding the impact that the COVID-19 pandemic has had on the conduct of oncology clinical trials,[i]  the COVID-19 pandemic has materially disrupted the conduct of clinical research and trials in much of the world.  The observed disruptors include an observed decrease in patient enrollment in clinical trials and the operational challenges arising from the need to protect patient safety and comply with the social distancing, shelter-in-place and other rules and regulations that have become key elements of the public health response to the pandemic.  As a result of these and other disrupters, investigators who participated in the Study reported that they are, “adopting or planning to adopt technology-based interventions aimed at reducing on-site monitoring visits and in-person patient visits to minimize potential viral exposure and spread, including telemedicine, remote electronic medical record access for monitors and virtual monitoring of data and study documentation.”
Continue Reading Going Virtual: Clinical Trials, Telemedicine, Electronic Medical Records, And All That.

In light of the widely reported shortage of personal protective equipment (PPE), ventilators, and other medical devices, the U.S. Food and Drug Administration (FDA) is working around the clock to authorize medical supplies for the US healthcare system, including relaxing its rules for importing and distributing PPE and ventilators and their accessories (e.g., vent splitters for multiple patient ventilation).  FDA’s policies on permitting uncleared medical devices shift daily toward greater relaxation of regulatory hurdles for suppliers and manufacturers.  The most recent policies on PPE importation and use in healthcare settings create more options for healthcare providers and patients in need of ventilatory support and help alleviate bottlenecks of necessary medical supplies in the supply chain.
Continue Reading Personal Protective Equipment & Ventilators: How FDA Is Increasing Supply for the US Healthcare System

On Friday, March 27, the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) was enacted.  Organized below are concise summaries of select CARES Act sections that will impact various sectors of the health care industry:
Continue Reading Key Health Care Provisions of the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”)

The U.S. Food and Drug Administration (FDA) issued two Emergency Use Authorizations (EUA) for commercially distributed COVID-19 diagnostic tests at the end of last week.  The first authorization was issued to Roche Molecular Systems, Inc., for its cobas SARS-CoV-2 Test, and the second issued the following day to Thermo Fisher Scientific, Inc., for its TaqPath COVID-19 Combo Kit.  Both tests are for the qualitative detection of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19). FDA granted the authorizations within 24 hours of receiving the requests.
Continue Reading FDA Grants COVID-19 Diagnostic Emergency Use Authorizations, And Other Recent FDA Actions to Address COVID-19

The FDA actions that dominated 2019 demonstrated a shifting regulatory landscape for certain product types, such as e-cigarettes, foods and supplements containing cannabidiol (CBD), and digital health / machine learning enabled medical devices. FDA continued to take action to lower drug prices by focusing on approvals of competitive biosimilars and generic drugs, and FDA enforcement actions signaled the Agency’s ongoing interest in ensuring GMP compliance overseas.
Continue Reading FDA Year in Review: A Shifting Regulatory Landscape

*This article was originally posted in Law360 on November 4, 2019

With the rise of artificial intelligence and machine learning, clinical decision support, or CDS, software presents a novel opportunity to analyze immensely large amounts of data for patterns or other information that may be relevant to a particular patient’s diagnosis or health care options.
Continue Reading Adapting To FDA’s Proposal For Diagnosis Support Software

On September 26, 2019, the US Food and Drug Administration (FDA) published six guidance documents clarifying its scope of authority and enforcement discretion policies in light of the 21st Century Cures Act (Cures Act). The long-awaited draft guidance on Clinical Decision Support (CDS) software sets forth FDA’s proposed approach to regulating CDS, including software that incorporates machine learning (ML) technology. Companies developing ML software for life science applications should consider reviewing FDA’s planned approach to inform their regulatory strategies.
Continue Reading New Set Of Guidance From FDA Provides Clarity On Digital Health Policies, Machine Learning

On September 19, 2019, FDA issued a guidance document, “Safety and Performance Based Pathway,” describing an optional pathway for medical devices with well-understood safety and performance profiles. The guidance signals FDA’s willingness to implement a more modern approach under the arcane 510(k) premarket pathway.
Continue Reading FDA’s New Safety and Performance Based Pathway for Medical Devices Reflects a More Modern Approach to Finding Substantial Equivalence

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.
Continue Reading Medical Devices – Artificial Intelligence and Reactions to FDA’s Proposed Oversight

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.
Continue Reading FDA Issues Warning Letter to Lab Marketing Three Laboratory-Developed Tests