FDA releases its yearly State of Pharmaceutical Quality report.
Senate HELP Committee ranking Democrat Patty Murray asks Olympus to answer questions arising from FDA data showing its closed-channel duodenoscopes ma...
FDA clears an eMurmur 510(k) for the eMurmur ID Solution for detecting heart murmurs.
PhRMA tells FDA that a draft guidance on Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients should be applicable across ot...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.