JD Supra

FDA Signals Major Shift for QMSR Transition for Medical Device Applications

Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...

Stereotaxis, Inc. (STXS) Q3 2025 Earnings Call Transcript

Q3 2025 Earnings Call November 11, 2025 4:30 PM ESTCompany ParticipantsDavid Fischel - CEO & ChairmanKimberly Peery - ...

U.S. FDA Approves KYGEVVITM (Doxecitine And Doxribtimine), The First And Only Treatment For Adults And Children Living With Thymidine Kinase 2 Deficiency (Tk2d)

The First And Only Treatment For Adults And Children Living With Thymidine Kinase 2 Deficiency (Tk2d). <li /> Approved indication: KYGEVVITM (doxecitine and doxribtimine) powder for oral solution (2 ...
Monthly Prescribing Reference

FDA: Administration Mix-Ups Prompt Tranexamic Acid Injection Label Changes

A Boxed Warning explaining the risk of medication errors involving inadvertent neuraxial administration will be added to the labeling. The Food and Drug Administration (FDA) has issued an updated ...
Hosted on MSN

FDA asked to update label on acetaminophen

A petition asks the FDA to change the label to better reflect research about a possible connection between acetaminophen use during pregnancy and autism. Trump administration looking to sell nearly ...
KY3

Maker of Tylenol pushing back on FDA proposal to add label suggesting link to autism

(CNN) - The maker of Tylenol is pushing back on a proposed change to the product’s safety label. Kenvue said the U.S. Food and Drug Administration should not change Tylenol’s label to reflect possible ...
MD&M East

FDA Challenges in 2025: How Medical Device Companies Can Navigate Agency Changes

As 2025 draws to a close, the state of the federal system of regulatory affairs in the United States continues to operate in a somewhat chaotic fashion. FDA has perhaps been most affected by changes ...