The U.S. dietary supplement industry continues to face mounting legal scrutiny as consumer class action lawsuits ...
In a major step toward streamlining biosimilar development, the U.S. Food and Drug Administration (FDA) has ...
As artificial intelligence (AI) reshapes nearly every sector, regulatory professionals are beginning to confront a ...
As Halloween festivities come to a close, the U.S. Consumer Product Safety Commission (CPSC) has announced a ...
Contamination control involves strategies and systems designed to prevent unwanted materials—chemical or ...
The checklist provides sponsors with detailed criteria for submission completeness—criteria that FDA reviewers ...
Radiopharmaceutical therapies deliver targeted radiation to cancer cells through a radioactive drug rather than ...
Wearable medical devices have rapidly evolved over the past decade. Modern tracking watches now measure more than ...
Over the past two years, several U.S. states have taken independent action to restrict or require warnings for ...
A recent Listeria monocytogenes outbreak has prompted a sweeping multi-state recall of prepared meals sold at ...
The European medical technology community is calling for sweeping reforms to the EU’s Medical Device Regulation ...
As the government shutdown stretches into its second week, the U.S. Food and Drug Administration (FDA) continues ...