The "FDA Inspection Preparedness and Compliance" training has been added to ResearchAndMarkets.com's offering. This is a practical, hands-on two-day seminar designed to provide pharmaceutical, ...

The U.S. Food and Drug Administration has lifted a clinical hold on three cell therapies being developed by CARsgen ...

The company stated in response to the Form 483 that it had “already taken ... progress when it came to remediating the FDA warning letters in an August 2024 earning call with analysts.

The warning letter, also known as a 483, identifies the concern(s), such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use. While ISO ...

especially regarding the status of iRhythm's remediation efforts in response to a 2023 warning letter from the FDA and their more recent 483 observations. As many of you know, iRhythm is in the ...

A Form 483 is issued when the agency feels it has ... but it is also worth noting that the FDA's warning letter apparently also accused iRhythm of failing to report patient deaths in a timely ...

In the warning letter, the FDA cited deficiencies in the response letters sent by the Company to the FDA following the Form 483, List of Investigational Observations, which was delivered to the ...

While uncertainty often casts a shadow on the Street, U.S. investors welcomed the presidential and congressional election results with a late-night surge that carried into this morning. The Dow Jones ...