FDA addresses whether parametric release is an appropriate control strategy for sterile drug products that are not terminally sterilized.
FDA grants Genprex an orphan drug designation for Reqorsa immunogene therapy (quratusugene ozeplasmid) and its use for treating small cell lung cancer...
Federal Register notice: FDA makes available a draft guidance entitled Postmarketing Approaches to Obtain Data on Under-Represented Populations in Cli...
Federal Register notice: FDA makes available a draft guidance entitled Classification Categories for Certain Supplements Under BsUFA III.
Federal Register notice: FDA determines that Baudax Bios Anjeso (meloxicam) solution, 30 mg/mL, was not withdrawn from sale due to safety or effective...
FDA publishes a draft guidance with information on prior approval supplement classification categories A-F.
Federal Register notice: FDA seeks stakeholder comments on a Drug Supply Chain Security Act-mandated technology and software assessment that examines ...
Federal Register notice: FDA sends to OMB an information collection extension entitled Radioactive Drug Research Committees.
