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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
The FDA has added Chagas disease and neurocysticercosis to the list of treatments for tropical diseases eligible for priority review vouchers, bringing the number to 19. Read More
CDER has revised its policies and procedures guide on responding to inquiries about ANDAs, clarifying responsibilities for Office of Generic Drugs and Office of Pharmaceutical Quality staff. Read More