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Info Collection on Medical Product Communications
[78 Words]
[ Price : $8.95]
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| 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.” |
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05/07/2021
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Pfizer/BioNTech Rolling BLA for Covid Vaccine
[97 Words]
[ Price : $8.95]
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| 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. |
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05/07/2021
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Condom Labeling Information Collection
[55 Words]
[ Price : $8.95]
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| 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. |
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05/07/2021
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Panel Split Vote on ChemoCentryx NDA
[336 Words]
[ Price : $8.95]
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| 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. |
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05/07/2021
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Breakthrough Designation for Oral Cancer Detector
[125 Words]
[ Price : $8.95]
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| 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. |
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05/07/2021
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FDA Priority Review for Keytruda Plus Lenvima
[2644 Words]
[ Price : $8.95]
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| 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. |
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05/06/2021
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