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FDA says it no longer sees the potential for excess mortality in paclitaxel-coated devices used to treat peripheral arterial disea...[ Price : $8.95]
FDA publishes a draft guidance recommending how to optimize and standardize dietary management in clinical trials of drugs to trea...[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension entitled Emergency Use Authorization of Medical Prod...[ Price : $8.95]
CDER researchers say a five-item questionnaire they developed successfully used patient-reported data to evaluate frailty in multi...[ Price : $8.95]
PhRMA asks the Supreme Court to reverse an 11th Circuit Appeals Court decision that held Shire could unilaterally change the Highl...[ Price : $8.95]
FDA develops a policy for the use of enforcement discretion for unauthorized tests in public health emergencies.[ Price : $8.95]
FDA issues a complete response letter for the Xspray Pharma Dasynoc NDA, asking for additional dosing information and information ...