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 posts four draft guidances on the use of real-world data and real-world evidence in regulatory decision-making, covering topics related to data so...
Federal Register notice: FDA makes available a final guidance entitled Principles of Premarket Pathways for Combination Products.
Federal Register notice: FDA renews for an additional two years its Vaccines and Related Biological Products Advisory Committee.
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...