For years, the Food and Drug Administration has been warning women about hormone therapies to treat menopause symptoms. The ...

Glenmark’s backlogged testing “was overdue by 3 months or longer for a large proportion of your samples,” the FDA wrote in ...

Master FDA expectations and best practices. Learn about facility design, personnel qualification, and contamination control, tackling FDA scrutiny and aligning with EU Annex 1 & ICH Q9/Q10 principles.

The US Food and Drug Administration has issued 7 warning letters to companies illegally marketing products containing 7-hydroxymitragynine (7-OH), which is found in trace amounts in kratom.

Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to ...

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

The defect has resulted in problems including a procedural delay, difficulty removing device fragments and bleeding, the FDA ...

The FDA cracked down on two plants in India and one in Korea in separate recently released reports, citing issues ranging ...

Glenmark Pharmaceuticals receives FDA warning letter for Indore facility, commits to resolving compliance issues promptly.

Consumers are urged to discard or return the affected products as the FDA warns that they could cause serious health issues or death.

The goal is to improve public understanding of the FDA decision-making process. (HealthDay News) — The U.S. Food and Drug Administration has published more than 200 complete response letters, or ...