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Tag Archives: labeling
Adaptive Designs and Clinical Supplies
In a recent post, John Johnson discussed the FDA’s draft guidance on Adaptive Design Clinical Trials for Drugs and Biologics, particularly in the context of planning and designing a clinical trial. My perspective concerns challenges related to clinical supplies (CS) … Continue reading
Posted in Clinical Trials
Tagged adaptive design, adaptive trials, analytical testing, API, clinical supplies, clinical trials, drug product, FDA, guidance, labeling, manufacturing
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Drug/Biologic/Device Highlights from the Health Care Reform Bill
Cautious, careful people, always casting about to preserve their reputations… can never effect a reform. – Susan B. Anthony Last month, the company behind the FDA Law Blog, Hyman, Phelps & McNamara, P.C., prepared a memo that outlines the provisions … Continue reading
