New data seems to indicate an uptick in the percentage of premarket applications that receive a major deficiency letter. See what US FDA spokesperson Alison Hunt said about strategies to avoid them.

Japanese firm says it will end SHP647 development after trying unsuccessfully to find takers for GI drug similar to its blockbuster Entyvio, first flagged by European authorities over competition worries.

The Environmental Working Group and US PIRG suggest that beauty and personal-care firms should avoid using talc in loose powders, if not all cosmetic products, and that the US FDA should consider banning the ingredient due to the potential for asbestos contamination, among other concerns.