Do: Respond within 15 business days of the original letter and be specific in that response. “It’s important to critically ...

Both warnings letters were issued after multiple inspections and following failures to respond to FDA 483a forms issued at ...

The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek ...

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

U.S. Secretary of Health and Human Services Robert Kennedy Jr. directed the Food and Drug Administration on Monday to revise ...

Dexcom announced today that it received a warning letter from the FDA following inspections of two company facilities.

Yesterday, the U.S. Food and Drug Administration (FDA) updated its website to provide new information on data integrity concerns relating to ...

In a regulatory filing, DexCom (DXCM) disclosed that on March 4, the company received a warning letter from the U.S. FDA following inspections ...

FDA took issue with the promotional communication presented in an exhibit booth panel (“panel”) [2] for Hemady ®, a drug indicated in combination with other anti-myeloma products for the treatment of ...

The FDA maintains a public inventory where all notices, supporting data and response letters are available for review. A few months ago, the FDA had set in motion a restructuring of its food ...

The "FDA Inspection" training has been added to ResearchAndMarkets.com's offering. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no ...