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Johnson & Johnson is facing lawsuits in two states that allege the company engaged in deceptive marketing claims for “new and revolutionary” surgical mesh used to treat women with pelvic organ prolapse. Read More
The FDA is accusing a medical devicemaker of neglecting to report five cases of radiation leakage from its products and other reporting violations, according to a 10-observation Form 483. Read More
Malaysia’s Medical Device Authority is encouraging companies to include information on how long it will take to complete the recalls in standard operating procedures. Read More
More federal regulators are knocking on Theranos’ door, keen on getting answers to questions about staff qualifications and improper review of patient test results. Read More