In a regulatory filing on Monday, Integra LifeSciences (IART) said that on December 19, 2024, a subsidiary received a warning letter from the ...

In a warning letter posted online late last month, the FDA scolded Viatris over a range of production slights at the ...

Integra Lifesciences recently received an FDA warning letter pertaining to quality systems issues at several facilities.

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...

Anderson, MS, MBA, is a former FDA Review Chemist with over 43 years ... compliance remediation services to resolve Form 483, Warning Letter, and Consent Decree issues.

In separate DLL3 antibody-drug conjugate (ADC) deals, Roche licensed from Innovent Biologics and Ideaya reached for Hengrui.

Has your company received an FTC warning letter or a penalty offense notice? If so, such correspondence should not be ignored because there is a high likelihood that the FTC is in the process of ...

The FDA has issued an early warning regarding Medline Fluid Delivery Sets, which may pose a significant health risk due to a potentially incorrect assembly, according to a Dec. 30 news release ...

Former commissioner of the Food and Drug Administration (FDA) Scott Gottlieb and Luciana Borio, a former director for medical and biodefense preparedness policy at the National Security Council ...

In one of the biggest deals worldwide for a biosimilar brand, Ahmedabad-based Intas agreed to buy Udenyca-the brand name for ...