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Newsletter - March 21, 2019

Do You Trust FDA to Assure Safety Of Approved Products? 
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A recent study by researchers from MIT and Harvard University raise concerns about the risks of adverse reactions due to excipients in drugs, reporting that more than 93% of drugs containing inactive ingredients that could cause allergic reactions. The study, though well-intentioned, could create unreasonable anxiety and fear in patients.. Read More

FDA Would Like Sponsors to Modernize Clinical Trials

FDA prefers that legacy clinical trial programs where a given product is tested through long clinical trials with generalized designs be replaced with modernized clinical development programs containing enrichment strategies, adaptive designs, master protocols,​ and operations supported by mobile technologies. Read More

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