On March 27, 2019, the FDA announced that it would be proposing new amendments to key regulations regarding mammography facilities that would require these entities “to tell women more about how dense breast tissue can affect their health and increase their cancer risk.” The proposed changes to mammography facility regulations would be the first issued
On April 2, 2019, FDA issued a press release featuring a statement from FDA Commissioner Scott Gottlieb announcing the Agency’s latest enforcement actions taken against companies engaging in unlawful marketing of cannabidiol (CBD) products. Coming just days before Gottlieb’s anticipated departure from the Agency, this news otherwise is unsurprising given recent events on the federal
Many physicians rely on publicly available reports to assess the safety of the devices they use on patients, but in some cases, these reports aren’t painting the full picture. A recent Kaiser Health News (“KHN”) article raises serious questions about FDA’s practice of allowing a significant number of medical device injury and malfunction reports to
On February 15, 2019, the U.S. Food and Drug Administration (“FDA”) finalized two guidance documents regarding regenerative medicine therapies (see FDA’s announcement here). This development comes nearly 14 months after FDA issued both guidance documents in draft form, which also coincided with FDA’s announcement of a new comprehensive regenerative medicine policy framework intended to
Gummies, brownies, sodas, cookies . . . consumer appetite for food and dietary supplement products containing cannabidiol (“CBD”) has grown over the last few years as states have moved to legalize cannabis for medical or limited recreational use. With the passage of the 2018 Farm Bill on December 20, 2018, which legalized the cultivation of
Data is king! A robust privacy, security and data governance approach to data management can position an organization to avoid pitfalls and maximize value from its data strategy. In fact, some of the largest market cap firms have successfully harnessed the power of data for quite some time. To illustrate this point, the Economist boldly
On December 11, 2018, the Food and Drug Administrative (“FDA”) issued a draft guidance for comment entitled, “Biomarker Qualification: Evidentiary Framework” (the “Guidance”). The Guidance provides insight regarding standards for biomarker qualification under the 21st Century Cures Act (“Cures Act”).
FDA defines the term “biomarker” as a “characteristic that is measured as an indicator
On October 18, 2018, the FDA published Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. This guidance outlined recommendations for cybersecurity device design and labeling as well as important documents that should be included in premarket approval submissions. This guidance comes at a critical time as the healthcare industry is a
The federal government entered into a partial shutdown at midnight on Saturday, December 22, 2018. The implications of the ongoing shutdown are far-reaching, but its impact on the Food and Drug Administration (“FDA”) is of particular concern to members of FDA-regulated industries and those with a role in ensuring the public health. Thousands of FDA
On December 7, 2018, the U.S. Food and Drug Administration (“FDA”) published a proposed rule (“Proposed Rule”) that, if finalized, would clarify the de novo classification process for medical devices, including (1) the format and contents of a de novo request and (2) the criteria for accepting or denying a de novo request.