Due to its authority having expired on 5/11 with the end of the Covid-10 public health emergency (PHE), FDA now urges medical device makers to maintai...
FDAs Pulmonary-Allergy Drug Advisory Committee votes to recommend approval for ARS Pharmaceuticals neffy (epinephrine) nasal spray for treating severe...
FDA eases its recommendations for evaluating potential blood donors for HIV.
FDA says a Cook Medical 4/7 recall of a tracheostomy introducer is Class 1.
FDA approves an Otsuka Pharmaceutical and Lundbeck supplemental NDA for Rexulti (brexpriprazole) oral tablets for treating agitation associated with d...
Three stakeholder groups and seven individuals call for FDA to promptly approve a Knowledge Ecology International 2020 petition to ban music in DTC ad...
FDA commissioner Robert Califf and chief medical officer Hilary Marston describe ways the agency will be better able to address future public health e...
Federal Register notice: FDA releases a discussion paper entitled Using Artificial Intelligence (AI) and Machine Learning (ML) in the Development of D...
