FDA says it has qualified INSPIRE questionnaires through the medical device development tool program to assess the impact of automated insulin dosing ...
FDA warns Nanobots Healthcare about violations in its production of sterile drugs.
FDA warns BioPure Healing Products that its dietary supplements are adulterated and misbranded.
Due to an inspection moratorium, FDA sends Nabriva Therapeutics a complete response letter on its NDA resubmission seeking marketing approval of Conte...
The Informed Consent Action Network petitions FDA to require a saline placebo control group in all Phase 2 or 3 clinical trials of Covid-19 vaccine ca...
Two George Mason University researchers make a case for transferring food regulation from FDA to the Agriculture Department so FDA can better focus on...
Federal Register notice: FDA determines that Promius Pharmas Tenex (guanfacine HCl) tablets, 1mg, 2mg,and 3mg were not withdrawn from sale for reasons...
FDA commissioner Stephen Hahn praises agency medical product review staff for maintaining the pace of reviews and actions during the pandemic.