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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.

CVOID 19; EUA…
Continue Reading FDA Grants COVID-19 Diagnostic Emergency Use Authorizations, And Other Recent FDA Actions to Address COVID-19

U.S. Food and Drug Administration (FDA) Commissioner Stephen M. Hahn, M.D., announced that FDA is postponing foreign inspections through April 2020 in response to the COVID-19 outbreak.  Manufacturers, including contract manufacturers, anticipating post-approval inspections may welcome the news, given other pressing issues facing ex-US facilities (i.e., facilities located outside the US) in light of COVID-19.  Companies with planned pre-approval inspections, however, may find the news distressing.
Continue Reading FDA Postpones Ex-US Facility Inspections

The nation’s reaction to the Coronavirus Disease (COVID-19) has been fierce—maybe unprecedented.  Information so far suggests that most COVID-19 illness is mild, yet the reaction from global markets has been drastic.  The US Food and Drug Administration (FDA) is closely monitoring the impact of the Coronavirus on the global drug supply chain and is focused on identifying and alleviating drug shortages before they happen.  The FDA also is using emergency measures to provide access to diagnostic tests and other medicines that would not otherwise be available to the public.
Continue Reading How FDA is Reacting to the Coronavirus, and 2020 Regulatory Priorities

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

This post was originally published on MD+DI.com.

As a lawyer with extensive experience in good manufacturing practice (GMP) issues, clients will ask me to review complex Quality System investigations. My clients are typically in-house counsel and, while review by Legal makes sense to a company’s in-house counsel (after all they, too, are lawyers), Quality or Manufacturing personnel often are flummoxed.
Continue Reading Tips for When to Consider Legal Review of Quality System Investigations

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

On July 10, 2019 Ned Sharpless, M.D., the Acting Commissioner of the Food and Drug Administration (FDA) issued a statement reaffirming FDA’s commitment to overseeing the manufacturing, marketing, and sale of e-cigarettes. The statement outlined FDA’s current and anticipated regulation of e-cigarettes, and discussed the balance of keeping e-cigarettes out of the hands of minors while exploring the potential for e-cigarettes to reduce adult smoking of more harmful tobacco products.
Continue Reading Regulating E-Cigarettes Remains “Top Priority” For FDA

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

The Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) within the US Food and drug Administration (FDA) published its annual “Report on the Sate of Pharmaceutical Quality” last week. The yearly report reviews the quality of drug products during the prior year, as measured by recall and product defect information, site inspections of manufacturers, and other post market data. The report provides a few insights that companies may want to consider when working with, or acquiring, contract manufacturers.  …
Continue Reading Location Matters – Manufacturing Insights from FDA’s Annual Report on Drug Quality

On May 1, 2019, AAFCO provided updated guidelines regarding the use of hemp in animal food, including how this market is affected by the Agricultural Improvement Act of 2018 (the “Farm Bill”). Although the AAFCO is not a government agency, its members are government agencies that represent the 50 states, the US Food and Drug Administration (FDA) Center for Veterinary Medicine, and the Canadian Food Inspection Agency. …
Continue Reading AAFCO Issues Updated Guidelines Regarding Hemp in Animal Food