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 ...
In its latest warning letter, FDA raised concern that the company was still producing eye drops with amniotic fluid, even ...
The Food and Drug Administration (FDA) recently issued warning letters to two third-party nonclinical testing laboratories.
The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement ...
The maker of a homeopathic nasal spray with a history of contamination is refusing to recall its product after the Food and ...
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 ...
The situation began to unravel on July 7, 2023, when Outset Medical announced it had received a warning letter from the FDA. The letter asserted that the company was promoting a Tablo product ...
From truckloads of torn documents to avian incursions in the production plant, Granules India’s recent manufacturing ...
A letter from the FDA rejecting Merck Sharpe & Dohme Corp.'s proposed label warning that its osteoporosis drug Fosamax could cause stress fractures doesn’t preempt state law claims alleging the ...
The USFDA's inspection of the facility took place from April 15 to 23, 2024, uncovering significant breaches of CGMP ...
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 ...
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