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The Government Accountability Office said medical device companies lack incentive to enroll participants in a post-market safety study requested by the FDA, and are slow to report findings. Read More
Inadequate processes for validating the facility’s water system, controlling purchased products and accepting incoming products were some of the issues flagged. Read More
A CAPA report showed manufacturing errors that led to many low patient results were caused by a failure to update manufacturing procedures after a design change, the agency said. Read More
Three members of Congress sent a letter to FDA Commissioner Scott Gottlieb to request a meeting to address the agency’s inaction on the numerous reports of adverse events associated with Bayer’s contraceptive device Essure. Read More