FDA issues a guidance with its current thinking on the regulatory criteria for human cells, tissue, and cellular and tissue-based product minimal mani...
FDA clears a Paige 510(k) for the FullFocus, a digital pathology image viewer for the purpose of primary diagnosis.
FDA releases its latest batch of Warning Letters that includes Centurion Medical Products, Signa SA de CV facility and Stason Pharmaceuticals.
FDA extends by six months its enforcement discretion policy for certain human cell, tissue, and cellular and tissue-based products due to the Covid-19...
FDA says it is currently reviewing its internal laboratory safety program to align with ongoing, shifting, and future priorities.
FDA accepts for review an Acadia Pharmaceuticals supplemental NDA for Nuplazid (pimavanserin) for treating hallucinations and delusions associated wit...
Pfizer and BioNTech report positive data from an ongoing German Phase 1/2 trial involving its mRNA-based BNT162 coronavirus vaccine program.
FDA reissues an emergency use authorization to Quest Diagnostics to authorize its Quest SARS-CoV-2 rRT-PCR test for pooled Covid-19 specimen samples.