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Pfizer/BioNTech Filing Covid Vaccine EUA in Days

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Pfizer and BioNTech plan to submit within days an Emergency Use Authorization request for their Covid-19 vaccine candidate BNT162b...

Info Collection on Expedited Drug Programs

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Federal Register notice: FDA seeks comments on an information collection extension entitled Expedited Programs for Serious Conditi...

Drug Compounding Registration Info Collection

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Federal Register notice: FDA sends to OMB an information collection revision related to the registration of human drug compounding...

HHS Speaker Program Fraud Alert

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The HHS Inspector General says drug and device companies and healthcare professionals should weigh the risks when considering whet...

NDA Withdrawal Notice Corrected

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Federal Register notice: FDA corrects a notice that appeared in the 1/8 Federal Register announcing the approval withdrawals for 1...

Grassley, Warren Seek FDA Hearing Aid OTC Rule Action

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Sens. Grassley and Warren ask FDA to promptly issue its proposed rule on OTC hearing aids.

Roxadustat Restrictions Sought

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A petition submitted for an unnamed client asks FDA not to approve roxadustat for treating anemia in patients with chronic kidney ...

Comments on Geriatric Info Drug Labeling Guidance

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Stakeholders suggest changes to an FDA draft guidance on including geriatric information in drug labeling.

More Benefits Than Risks in Excluded Software: FDA

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In its second biennial report required by the 21st Century Cures Act, FDA says that software not considered a medical device gener...

FDA Will Review Lucentis Biosimilar BLA

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FDA says it will review the Samsung Bioepsis/Biogen BLA for a biosimilar of Genentechs Lucentis.