Although the side effect is rare, the FDA said some patients experienced severe itching that required medical attention.

The FDA has told vaccine manufacturers to expand the warning labels on their COVID-19 shots with more information about the ...

The US Food and Drug Administration will now require Covid-19 vaccines from Pfizer/BioNTech and Moderna to use expanded warning labels with more information about the risk of a rare heart condition ...

FDA approves three color additives derived from natural sources. In order to “expand the palette of available colors from natural sources ...

FDA inspections are essential to ensuring the safety and quality of products in the food, pharmaceutical, and medical device industries. One of the experienced professionals in this field is John ...

Food safety warning letters have stalled at the FDA after the agency temporarily laid off the staff who review them.

Zhong Li’s extensive history with the FDA offers crucial lessons on how companies in the pharmaceutical and biopharmaceutical sectors should approach inspection preparedness.  As an experienced FDA ...

The FDA is warning consumers about the dangers of tianeptine, a drug being sold at gas stations, convenience stores, vape ...

The use of tianeptine has increased in recent years in the U.S. however the product is not approved by the FDA.

The Food and Drug Administration laid out these inspection findings in warning letters, accusing the companies of committing “significant violations” of federal laws, according to an FDA staff ...