The Food and Drug Administration (FDA) recently issued warning letters to two third-party nonclinical testing laboratories.
The maker of a homeopathic nasal spray with a history of contamination is refusing to recall its product after the Food and ...
iRhythm’s stock price has been volatile over the past five years, climbing as high as $274.21 and declining as low as $41.66. It was down 30 percent for 2024 and stood at $86.25 the day before the ...
The FDA has issued a warning letter to Regenerative Processing Plant after conducting an inspection of the facility. The plant manufactures two ophthalmic drug products, Regener-Eyes Professional ...
In its latest warning letter, FDA raised concern that the company was still producing eye drops with amniotic fluid, even ...
The U.S. Food and Drug Administration's (FDA) warning letter to Agena Bioscience, issued on March 21, 2024, marks a significant shift in enforcement priorities, targeting the improper labeling of ...
The FDA is considering food labels to help consumers identify products with unhealthy ingredients, but some experts wonder if ...
The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement ...
The US health regulator has pulled up Zydus Lifesciences for manufacturing lapses at its Gujarat -based plant. In a warning ...
The FDA has issued more than 690 warning letters and more than 140 civil money penalty actions to retailers for the sale of ...
Two senators want to empower the FDA to send warning letters to influencers and telehealth companies that publish deceptive ...
The FDA said the problems “raise concerns about the quality and integrity of data generated by the labs,” which provide third-party testing and validation data services for device firms.