PhRMA tells FDA that a draft guidance on Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients should be applicable across ot...
Akin Gump attorneys update FDA enforcement actions involving laboratory-developed tests.
FDA releases its latest batch of Warning Letters that includes one medical product company Petra Hygienic Systems.
A New York Times article questions generic drug safety and quality, leading to a defensive post from CDER director Janet Woodcock about the agencys ov...
Federal Register notice: FDA determines the regulatory review period for W.L. Gore & Associates Gore Viabahn VBX Balloon Expandable Endoprosthesis.
Federal Register notice: FDA announces a 6/7 public meeting entitled Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Bios...
FDA reviewers question the robustness of data submitted in a Daiichi-Sankyo NDA for quizartinib, indicated for treating adults with relapsed or refrac...
FDA clears a Zebra Medical Vision 510(k) for the HealthPNX, an artificial intelligence alert for pneumothorax, based on chest x-rays.