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OMB Approves 6 FDA Information Collections

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Federal Register notice: FDA announces that OMB has approved six information collections.

Info Collection on Medical Product Communications

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Federal Register notice: FDA seeks comments on an information collection extension entitled Medical Product Communications That Ar...

Pfizer/BioNTech Rolling BLA for Covid Vaccine

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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...

Condom Labeling Information Collection

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Federal Register notice: FDA sends to OMB and information collection extension entitled Class 2 Special Controls Guidance Document...

Panel Split Vote on ChemoCentryx NDA

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An FDA advisory committee splits on whether the efficacy data support approval for a ChemoCentryx NDA for avacopan targeting anti-...

Breakthrough Designation for Oral Cancer Detector

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FDA grants Viome a breakthrough device designation for its proprietary mRNA analysis technology combined with its artificial intel...

10 Observations in Hospira FDA-483

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FDA releases the FDA-483 with 10 observations issued following an inspection six months ago at Hospiras sterile drug manufacturing...

Info Collection on Device Classification Inquiries

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Federal Register notice: FDA sends to OMB an information collection extension entitled 513(g) Request for Information for device c...

FDA Priority Review for Keytruda Plus Lenvima

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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...

Pharmacy Compounding Advisory Panel Meets 6/9

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Federal Register notice: FDA announces a 6/9 Pharmacy Compounding Advisory Committee meeting to discuss four bulk drug substances.