The month in life sciences and intellectual property
In our most recent Synthesis issue, the month in life sciences and intellectual property news: Defining the limits of protection that skinny labels afford; the impact of
Continue Reading Synthesis, Issue 5
On January 21, 2024, the FDA issued a final rule amending its Quality System (QS) regulations under 21 CFR Part 820, which addresses current good manufacturing practice (CGMP) requirements for medical device manufacturers. The amendments
Continue Reading FDA’s new Quality Management System Regulation is here: Key takeaways for device companies in US, EU, and China
Written by: Bethany Hills, Adam Donat
The Food and Drug Administration (FDA) has released a draft guidance titled, “Good Clinical Practice (GCP) E6(R3),” explaining how the Agency plans to apply its regulations
Continue Reading Guest Blog: FDA aims for international harmonization and modernized clinical trials
FDA regulates prescription drug advertising under the authority of the Federal Food, Drug, and Cosmetic Act (FDCA) and the implementing regulations. In 2018, after observing an increase in quantitative presentations of efficacy and risk information
Continue Reading Key updates from FDA’s latest guidance on presenting efficacy and risk data in DTC promotion
FDA continues CBD enforcement and ramps up delta-8 THC enforcement; agency focuses on youth-appealing products.
To learn about these developments and their implications for your business, continue reading here.
Continue Reading FDA continues CBD enforcement and ramps up delta-8 THC enforcement; agency focuses on youth-appealing products
This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape.
The Food and Drug Administration (FDA) continues to address potential cybersecurity issues implicated by the rise in digital health and digital medical devices. In its latest move, the FDA recently released a discussion paper, “
Continue Reading FDA seeks feedback on industry best practices for medical device cybersecurity communications
This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape.
This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape.
According to public statements from the US Food and Drug Administration (FDA), United States Department of Agriculture (USDA), US Center for Disease Control (CDC), and similarly situated international bodies, there is no current indication based
Continue Reading COVID-19 and food – FDA position (United States)
