Latest Posts › Life Sciences

Share:

FDA Finalizes Guidance on Scientific Information on Unapproved Uses (SIUU) Communications

On January 6, 2025, FDA published a final version of its guidance document, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products.” This...more

Loper Bright's Implications for the Food and Drug Administration and Regulated Industry

Under the Chevron doctrine, FDA and other agencies had significant flexibility to set policy where Congress left a gap or failed to speak clearly when enacting legislation—a common occurrence given the at-times sparse...more

Action Plans on Diversity: Key Requirements for Certain Clinical Studies

On June 26, 2024, FDA issued a new draft guidance on clinical trial diversity, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies” (Draft Guidance), to assist...more

Harmonization Is Key: FDA’s Proposed Rule Seeks to Revamp Medical Device Quality System Regulation

On February 23, 2022, the U.S. Food and Drug Administration (FDA) issued a proposed rule seeking to amend the medical device current good manufacturing practice requirements of the Quality System Regulation (QSR). Currently,...more

Caught in FDA’s Crosshairs: Delta-8 THC Products Invite Increased Scrutiny

The Food and Drug Administration (FDA) issued a consumer alert related to Delta-8 tetrahydrocannabinol (Delta-8 THC), following a recent increase in adverse event reports to FDA and poison control centers. Although Delta-8...more

5 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide