FDA denies an 8/2018 Pfizer petition urging it to tighten bioequivalence requirements for any ANDA submitter seeking to gain approval for generic copi...
FDA clears a Masimo 510(k) for the measurement of respiration rate from the pleth on the MightySat Rx spot-check fingertip pulse oximeter, as well as ...
FDA approves an expanded use for AbbVies Imbruvica (ibrutinib) combination use with Gazyva (obinutuzumab) for adult patients with previously untreate...
CDRH says it approved a record 106 novel devices, eclipsing the 40-year record it set in 2017 when 99 such devices were approved.
A welcome back email from CDER director Janet Woodcock tells employees returning to work from the just-ended partial government shutdown to pick up th...
FDA Review posts product approval summaries for the week ending 1/25/2019.
Centerline Biomedical files a 510(k) for the Intra-Operative Positioning System, a non-radiation-based surgical navigation system.
Draeger Medical recalls (Class 1) its VentStar and ID Breathing Circuits and Anesthesia Sets manufactured 1/2016 to 11/2018 due to incorrect assembly ...