FDA issues a final guidance entitled Opioid Use Disorder (OUD): Developing Buprenorphine Depot Products for Treatment.
FDA releases a draft guidance entitled: Eosinophilic Esophagitis (EoE): Developing Drugs for Treatment that assists sponsors with their clinical devel...
Federal Register notice: FDA announces a 5/1 public workshop entitled FY 2019 Generic Drug Regulatory Science Initiatives.
Federal Register notice: FDA announces a joint 2/12 advisory committee meeting to review a Janssen Pharmaceuticals NDA for depression.
Stakeholders suggest revisions to an ICH draft guidance on pharmaceutical product lifecycle management technical and regulatory considerations.
Stakeholders say FDA has done a good job in developing a framework for using real-world evidence to support some drug approvals and post-approval stud...
Stakeholders suggest improvements to a draft FDA guidance on early drug development for rare diseases and the role of pre-IND meetings.
FDA approves a Ablynx BLA for Cablivi (caplacizumab-yhdp) injection, the first therapy specifically indicated, in combination with plasma exchange and...