FDA's Pazdur Advocates Platform Trials For Cancer Drug Development
US FDA is encouraging common mechanisms of drug testing to enable pharma industry collaboration and avoid redundancy; Pazdur notes that there are many similar PD-1 drugs.
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Woodcock Hopes I-SPY 2 Trial Is 'Blazing The Trail' For Future Adaptive Design Uptake
CDER director renews US FDA's support for complex trials, but acknowledges that sponsors are still hesitant to adopt them.
False Claims Act Liability: Defendant’s Belief Claims Were False Matters, Supreme Court Finds
In unanimous decision, court backs whistleblowers’ fraud theory that SuperValu and Safeway defrauded Medicare and Medicaid by reporting higher retail prices than their discounted prices. BIO, AdvaMed and MIWG submitted amicus brief in support of the retail pharmacies.
DOJ Enforcement: Talking With US FDA Is Not Enough To Get Credit For Self-Disclosure
Remediation of a problem with FDA is one factor the DOJ considers in assessing whether a company gets credit for self-disclosure of misconduct prior to a criminal investigation, but it wants companies to come directly to the department to divulge wrongdoing.