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TXT OMB Approves 6 FDA Information Collections [234 Words] [ Price : $8.95]
Federal Register notice: FDA announces that OMB has approved six information collections.
05/07/2021
 
 
TXT Info Collection on Medical Product Communications [78 Words] [ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension entitled “Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers.”
05/07/2021
 
 
TXT Pfizer/BioNTech Rolling BLA for Covid Vaccine [97 Words] [ Price : $8.95]
Pfizer and BioNTech begin a rolling BLA to seek full approval of their mRNA vaccine to prevent Covid-19 in individuals 16 years of age and older.
05/07/2021
 
 
TXT Condom Labeling Information Collection [55 Words] [ Price : $8.95]
Federal Register notice: FDA sends to OMB and information collection extension entitled “Class 2 Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms — 21 CFR 884.5300.
05/07/2021
 
 
TXT Panel Split Vote on ChemoCentryx NDA [336 Words] [ Price : $8.95]
An FDA advisory committee splits on whether the efficacy data support approval for a ChemoCentryx NDA for avacopan targeting anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis.
05/07/2021
 
 
TXT Breakthrough Designation for Oral Cancer Detector [125 Words] [ Price : $8.95]
FDA grants Viome a breakthrough device designation for its proprietary mRNA analysis technology combined with its artificial intelligence platform for use in early detection of oral and throat cancer.
05/07/2021
 
 
TXT Info Collection on Device Classification Inquiries [78 Words] [ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension entitled “513(g) Request for Information” for device classification inquiries.
05/06/2021
 
 
TXT FDA Priority Review for Keytruda Plus Lenvima [2644 Words] [ Price : $8.95]
FDA gives priority review to two applications from Merck and Eisai for the combination of Keytruda and Lenvima to treat some cases of advanced renal cell or endometrial carcinoma.
05/06/2021
 
 
TXT Pharmacy Compounding Advisory Panel Meets 6/9 [72 Words] [ Price : $8.95]
Federal Register notice: FDA announces a 6/9 Pharmacy Compounding Advisory Committee meeting to discuss four bulk drug substances.
05/06/2021
 
 
TXT Check Aluminum Levels in 13 Vaccines: Researcher [2785 Words] [ Price : $8.95]
A researcher from a British university says only three of 13 children’s vaccines tested contained the aluminum level stated in the labeling.
05/06/2021
 
 
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