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The proposal includes accelerated approvals of drugs, specified timelines for deciding applications and increased public access to information. Read More
The European Medicines Agency is seeking feedback on the International Conference on Harmonization’s revised E6 guideline, which adds new recommendations for sponsors on developing risk-based quality management systems for clinical trials. Read More
With more than 80 percent of APIs coming into the U.S. from foreign sites, the FDA is stepping up its enforcement activities to better manage global supply chains. At the same time, India and China are also expanding their inspection teams. Read More
The FDA is amending its color additive regulations to allow for the use of spirulina extract in coating formulations for drug tablets and capsules — giving drugmakers an alternative blue color that is exempt from safety certification requirements. Read More
The FDA is seeking input on how it can make its Inactive Ingredients Database more useful and user-friendly, following complaints by generic drug and excipient makers that the current format delays ANDA filings. Read More