Medical Device Legal News with Sam Bernstein: Episode 11
In January 2025, various US Food and Drug Administration (FDA) centers and offices published their guidance agendas for the 2025 calendar year (CY). These agendas provide valuable insights into FDA’s regulatory priorities,...more
For more than a decade, the Food and Drug Administration (FDA) has made diversity in clinical trials a focus, including by issuing guidance, convening public-private workshops, and completing data analyses in an effort to...more
• FDA issues a Proposed Rule to allow states and other entities to import certain prescription drugs from Canada. • In addition, FDA issues draft guidance for industry to explain how drug manufacturers can import their own...more
The FDA recently issued a draft guidance document intended to “to ensure that least burdensome principles are implemented for all device-related applications and interactions with FDA.” The FDA provides this draft guidance...more