Federal Register notice: FDA seeks comments on an information collection extension entitled Environmental Impact Considerations (OMB Control Number 09...
Baxter says it expects to deploy a software upgrade for its Spectrum IQ infusion pumps in the fourth quarter to address an issue experienced by some c...
FDA announces a 10/14 virtual public workshop on improving transparency of artificial intelligence/machine learning-enabled medical devices by enhanci...
Stealth BioTherapeutics says it has acceded to Barth syndrome patient community requests and submitted an NDA for elamipretide despite FDA concerns th...
Researchers evaluate 10 possible reforms to the FDA accelerated approval pathway.
FDA publishes a draft guidance on a pharmacokinetic approach to alternative dosing regimens for PD-1 and PD-L1 drugs.
FDA alerts health care personnel to stop using certain N95 respirators manufactured by Shanghai Dasheng Health Products Manufacturing Co. due to quali...
FDA has approved a Bayer sNDA extending to seven years the duration of use for the companys Mirena IUD birth control device.