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CDRH director Jeff Shuren tells an industry conference that FDA will likely favor a hybrid inspection program going forward in the...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled E9(R1) Statistical Principles for Clinical Trials: Addendum...[ Price : $8.95]
The Justice Department says a federal grand jury indicted a Miami clinical trial coordinator for conspiring to falsify clinical tr...[ Price : $8.95]
The 2nd Circuit Court of Appeals upholds a New York federal courts dismissal of a suit claiming that Pfizer failed to properly war...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled S11 Nonclinical Safety Testing in Support of Development of...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled S5(R3) Detection of Reproductive and Developmental Toxicity...[ Price : $8.95]
FDA says the Medtronic recall of its HeartWare HVAD system to update instructions for use and the patient manual due to three issu...[ Price : $8.95]
FDA approves a Johnson & Johnson Vision PMA for its Acuvue Abiliti Overnight Therapeutic Lenses, the first orthokeratology contact...