Day: March 21, 2019

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. Last week, FDA finalized two older guidance documents, one on enrichments strategies describing ways to … Read more

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 taking the same drugs. All … Read more