Federal Register notice: FDA announces the renewal of the Technical Electronic Product Radiation Safety Standards Committee for an additional two year...
Diverse stakeholders praise FDA for its draft guidance on REMS assessment and evaluation and offer recommendations for changes to be made to the docum...
O-Two Medical Technologies recalls its e700, e600 and e500 Automatic Transport Ventilators because an improperly inserted screw in the ventilator scre...
FDA warns Cord for Life it is selling unapproved umbilical cord blood products and says many firms producing stem cell products need to meet regulator...
Federal Register notice: FDA announces the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program.
FDA commissioner Scott Gottlieb and deputy commissioner Anna Abram discuss new agency efforts to improve the quality of drug compounding.
Sandoz resubmits its biosimilar pegfilgrastim (Amgens Neulasta) BLA to address a 6/2016 complete response letter.
FDA releases its latest batch of Warning Letters that include Dong Yuan Technology and Inopak Ltd.