The Coalition for Healthcare Communication reports that five research studies conducted by CDERs Office of Prescription Drug Promotion are awaiting pe...
Five stakeholders recommend changes to an FDA draft guidance on population pharmacokinetics.
FDA releases its latest batch of Warning Letters that includes Deb USA and 21st Century Scientific.
Former FDA commissioner Scott Gottlieb joins Aetions board of directors.
Six CDER staffers explain the new FDA Knowledge-aided Assessment & Structured Application system being developed and implemented to improve drug regul...
Takeda Pharmaceutical Co. recalls all doses of Natpara (parathyroid hormone) for injection due to a potential issue related to rubber particulate conc...
An FDA advisory committee recommends that FDA should develop standards for device companies to use when any cybersecurity concern is communicated to p...
Federal Register notice: FDA makes available 53 product-specific guidances (PSGs) 34 new guidances and 19 revised ones.