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

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

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 ...

The US FDA has published more than 200 complete response letters, or decision letters, sent as replies to drug and biological product applications submitted to the agency from 2020 to 2024.

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