Public Citizen calls for an immediate HHS Inspector General probe of what it terms FDA collaboration with Biogen on the companys Alzheimers drug aduca...
Three stakeholders comment on an FDA draft guidance on human gene therapy for neurodegenerative diseases.
FDA approves a NuVasive PMA for its Simplify Cervical Artificial Disc for two-level (XXX DELETE XXX) total disc replacement.
Three Sidley Austin attorneys writing for Washington Legal Foundation say a recent 4th Circuit Appeals Court decision increases the burden on plaintif...
FDA approves a Supernus Pharmaceuticals NDA for Qelbree (viloxazine extended-release capsules) for treating attention-deficit hyperactivity disorder i...
CDER posts a final guidance entitled Development of Abbreviated New Drug Applications During the Covid-19 Pandemic Questions and Answers.
FDA clears a Surgical Information Sciences 510(k) for an updated algorithm with new visualization capabilities for its SIS System.
FDA clears an Orthofix Medical 510(k) for its 3D-printed Construx Mini Ti Spacer System for use in enhancing anterior cervical discectomy and fusion p...