Elanco Animal Health (NYSE:ELAN) has received a warning letter from the FDA related to promotional materials for its canine drug Zenrelia. In the letter, the FDA said that an agency review of certain ...
Outset Medical (Nasdaq: OM) announced today that the FDA says it addressed all issues cited in a 2023 warning letter.
Elanco Animal Health Incorporated issued the following statement regarding its commitment to clear veterinary and pet owner ...
Outset Medical (OM) announced it has been notified by the FDA that all issues cited in a warning letter the company received in July of 2023 ...
Inc. (NASDAQ:OM), a medical technology company focused on innovating dialysis treatment, has resolved all concerns raised in a Warning Letter from the U.S. Food and Drug Administration (FDA) dating ...
FDA slaps China-based API makers with separate warning letters outlining quality, testing shortfalls
A pair of Chinese manufacturers with active pharmaceutical ingredients that were previously shipped to the U.S. | The FDA ...
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its ...
Hologic received a warning letter in December from the Food and Drug Administration related to safety concerns with the company’s Biozorb implantable radiographic markers. The FDA found that ...
We are pleased to achieve this important milestone and remain vigilant as we work to continuously improve everything we do on behalf of the patients and providers we serve.” About Outset Medical, Inc.
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