J&J Faces Possible Criminal Liability As Post-Recall Overhaul Continues
FDA could seek misdemeanor charges against J&J officers under the Park Doctrine, which can be invoked against executives who could have prevented adulteration or misbranding of a drug. California Republican Issa says regardless whether criminal indictments come, the case "could be fair warning" to other firms regarding quality system failures.
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In this first of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet how the use of alternatives to animal testing in drug development is gaining traction and discusses the challenges that exist.
The Senate Health, Education, Labor and Pensions Committee voted to advance Monarez's nomination to lead the CDC as the agency announced the largest US measles outbreak in 22 years.
The Pediatric Advisory Committee supported routine safety monitoring for three vaccines and 21 drugs, but the panel’s consumer representative said adverse event reporting needs improvement and FDA literature reviews should include lawsuits as well as social media.