FDA announces a 4/24 public workshop on the current status of the regulatory science initiatives for generic drugs.
FDA chooses Octo Consulting for a seven-year contract to modernize and streamline the drug and medical device approval process as required by the 21st...
Two stakeholders recommend changes to an FDA draft guidance on clinical decision support software.
FDA commissioner Scott Gottlieb says agency scientists have found new data confirming opioid properties and 44 deaths reported from use of abusable bo...
A CDER small business podcast says generic drug manufacturers can find ANDA submission help in a recent guidance aiming to reduce the number of review...
FDA posts a Form 483 from a 1/24-completed inspection of Houston, TX-based Empower Pharmacy that cites a repeat observation from an earlier inspection...
Federal Register notice: FDA classifies the percutaneous nerve stimulator for substance use disorders into Class 2 (special controls).
Federal Register notice: FDA submits to OMB an information collection extension for Animal Drug Adverse Event Reporting.