FDA issues an early alert warning healthcare providers about a potentially high-risk device issue involving introducer kits used with Impella heart pu...
FDA warns Amazon it is marketing unapproved new drugs on its Web site.
Former FDA commissioner Scott Gottlieb supports the agency's newly announced initiative to accelerate early-stage clinical trials, arguing that the p...
FDA sends Achieve Life Sciences a Complete Response Letter on its NDA for cytisinicline as a treatment for nicotine dependence.
FDA releases the form FDA-483 with two observations from an inspection at the Pharmaneek non-sterile drug manufacturing facility in Indianapolis, IN.
FDA closes a potential enforcement action against Whoop Inc., reversing an earlier regulatory position that raised questions about whether the company...
Drug company executives recommend ways FDA could increase the use of real-world evidence in regulatory decisions.
