As part of its enforcement activities, the Food and Drug Administration (FDA) sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or ...

The Lay’s potato chips recall for undeclared milk was upgraded to the FDA’s highest risk level. Find out what this means for ...

The U.S. Food & Drug Administration sent a warning letter to Frontier Biologics in November, outlining concerns about the company’s operations. But Frontier Biologics chief scientist Gene ...

On Jan. 15, 2025, a warning letter was sent to Sanofi stating that FDA inspectors found irregularities with the facility’s bioreactor, the vessel used to grow organisms and cells. According to ...

After years of legal wrangling surrounding Teva’s Copaxone, the latest hit to the lucrative multiple sclerosis drug comes in the form of a safety-related boxed warning. The label update ...

Piero Cingari FDA Warns Hologic Over BioZorb Manufacturing Violations FDA issues warning to Hologic, citing manufacturing and safety violations for BioZorb devices. Patient safety risks and ...

“Each of us has the privilege of free speech, but not without limits,” begins a letter sent to an Ontario Public School Boards’ Association board member by the chair of the Grand Erie ...

As you can see from the chart above the percentage of shares that are sold short for Hologic has grown since its last report. This does not mean that the stock is going to fall in the near-term ...

Warning labels must be attached to an asthma drug commonly prescribed to children in Australia after it was linked to suicidal thoughts, hallucinations and other psychiatric conditions.

The FDA has given the recall its highest risk level ... which produces the smoked salmon for Costco, sent a letter to Costco members who had purchased the recalled items to warn them against ...

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Here is what I found for readers who have noticed the same: Following false advertising suits and repeated failures to comply with the Food, Drug, and Cosmetics Act, Balance of Nature was ordered ...