Three stakeholders comment on an FDA draft guidance on human gene therapy for neurodegenerative diseases.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...
The Medical Device Innovation Consortium releases a new report entitled Maximizing Patient Input in the Design and Development of Medical Device Clini...