On May 31, 2019, the U.S. Food and Drug Administration (“FDA”) hosted its much-anticipated public hearing titled “Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds” (discussed in our prior blog post). The day-long hearing presented an opportunity for FDA panel members to engage directly with stakeholders on the regulatory future of
When we think about the top players in the medical device development space, we often see device company sponsors, clinicians, scientists, and FDA regulators as the ones driving the process. But what about the patient perspective? Does that get factored in?
On May 3, 2019, FDA established a docket to collect public input on a
Following a two-day meeting by a Food and Drug Administration (“FDA”) advisory committee on breast implant safety earlier this year, FDA on May 2, 2019, released a statement announcing that no breast implant models will be banned from the U.S. market at this time. Also described in the statement are a number of measures the
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