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.
FDA schedules a 5/13 public hearing to receive comment on developing and approving biosimilar and interchangeable insulin products.
Federal Register notice: FDA issues a priority review voucher to Siga Technologies for gaining approval of a material threat medical countermeasure pr...
Federal Register notice: FDA withdraws approval of 16 NDAs from multiple applicants.