CDER releases a list of 98 new and revised draft guidances intended for publication in 2022.
FDA clears a VySpine 510(k) for the ClariVy Cervical IBF System and its use in anterior cervical discectomy with fusion procedures.
FDA says the Empowered Diagnostics recall of more than 250,000 unapproved Covid-19 tests is Class 1.
A Florida federal judge sentences the founder of Blackstone Labs to 54 months in prison and orders him to forfeit $2.9 million for his role in a consp...
Bloomberg News reports that Pfizer/BioNTech are submitting rolling data for an EUA for Covid-19 vaccinations for kids between six months and four year...
Novavax has submitted an emergency use authorization for NVX-CoV2373, its protein-based Covid-19 vaccine candidate for adults 18 years of age and olde...
FDA issues sterile drug product maker Johnson Memorial Cancer Center a Form FDA-483 after a 10/2021 inspection cited GMP deficiencies.
A just-released CDRH annual report says it was able to grant marketing authorizations for 103 novel devices last year, despite being one of the busies...