Congresswoman Claudia Tenney (R-NY) introduces the Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act.
FDA says a Covid-19 guidance on container closure systems is expected to be effective until 8/7/2024.
Johnson & Johnson says it will submit an IDE in the second half of 2024 to start trials of its Ottava surgical robot.
CDER researchers say 39% of breakthrough therapy designation requests between 2017 and 2019 were approved by FDA.
FDA clears a Koru Medical Systems 510(k) for the Freedom60 Infusion System with Hizentra 50 mL prefilled syringes.
FDA grants Plus Therapeutics an orphan drug designation for rhenium obisbemeda, an injectable radiotherapy for treating breast cancer with leptomening...
FDA releases a final guidance entitled Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theor...
FDA reissues a guidance document entitled Process to Request a Review of FDAs Decision Not to Issue Certain Export Certificates for Devices.
