FDA commissioner Scott Gottlieb appoints CDRH deputy center director for policy Lauren Silvis as his chief of staff and Sidley Austin partner Rebecca ...
Researchers suggest ways to improve the approval process for soft tissue fillers used in nonsurgical cosmetic procedures.
FDA accepts for review a Churchill Pharmaceuticals NDA for Yonsa (abiraterone acetate) ultramicrosize tablets for treating metastatic castration-resis...
Med Prep Consulting executives plead guilty to conspiracy charges involving distribution of contaminated cancer drugs.
FDA releases the FDA-483 listing 14 observations from an agency inspection at Indias Intas Pharmaceutical.
FDA clears a DarioHealth 510(k) for the Dario Blood Glucose Monitoring app and its use on certain Android mobile devices.
CDERs Ilisa Bernstein blogs about a new medical product supply chain toolkit developed over four years by international regulators and stakeholders le...
Federal Register notice: FDA announces a 9/25 public meeting on Patient-Focused Drug Development for Hereditary Angioedema.