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TXT Paige Digital Pathology Viewer Cleared [209 Words] [ Price : $8.95]
FDA clears a Paige 510(k) for the FullFocus, a digital pathology image viewer for the purpose of primary diagnosis.
07/21/2020
 
 
TXT Latest FDA Warning Letters [369 Words] [ Price : $8.95]
FDA releases its latest batch of Warning Letters that includes Centurion Medical Products, Signa SA de CV facility and Stason Pharmaceuticals.
07/21/2020
 
 
TXT CGMP Violations at Stason Pharmaceuticals [2715 Words] [ Price : $8.95]
FDA warns Stason Pharmaceuticals about CGMP violations in its production of finished drugs.
07/21/2020
 
 
TXT Enforcement Discretion Extended on Regenerative Therapies [321 Words] [ Price : $8.95]
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 public health emergency.
07/20/2020
 
 
TXT FDA Tightening Internal Lab Safety [385 Words] [ Price : $8.95]
FDA says it is currently reviewing its internal laboratory safety program to align with ongoing, shifting, and future priorities.
07/20/2020
 
 
TXT Acadia sNDA for Dementia-related Hallucinations [128 Words] [ Price : $8.95]
FDA accepts for review an Acadia Pharmaceuticals supplemental NDA for Nuplazid (pimavanserin) for treating hallucinations and delusions associated with dementia-related psychosis.
07/20/2020
 
 
TXT Pfizer, BioNTech Positive Data on Covid Vaccine Program [249 Words] [ Price : $8.95]
Pfizer and BioNTech report positive data from an ongoing German Phase 1/2 trial involving its mRNA-based BNT162 coronavirus vaccine program.
07/20/2020
 
 
TXT FDA EUA for 1st Pooled Covid Test [164 Words] [ Price : $8.95]
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.
07/20/2020
 
 
TXT Guide on Viral Transport Media Enforcement [144 Words] [ Price : $8.95]
FDA posts a final guidance entitled “Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 Public Health Emergency.”
07/20/2020
 
 
TXT Positive Data on AstraZeneca Covid-19 Vaccine Trial [258 Words] [ Price : $8.95]
AstraZeneca reports positive interim data from an the ongoing Phase 1-2 COV001 trial, which showed that its AZD1222 vaccine was tolerated and generated “robust immune responses against the SARS-CoV-2 virus in all evaluated participants.”
07/20/2020
 
 
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