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Notice Corrected on Donor Eligibility Requirements
[81 Words]
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| Federal Register notice: FDA corrects a 5/24 notice on a draft guidance being made available entitled "Blood Pressure and Pulse Donor Eligibility Requirements: Compliance Policy” due to an incorrect comment period due date. |
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06/13/2022
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Pfizer, Moderna Vaccines Safe & Effective in Children: FDA
[273 Words]
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| As FDA prepares for a 6/14-15 advisory committee meeting on pediatric Covid-19 vaccines, agency briefing documents find the Pfizer-BioNTech and Moderna Covid-19 vaccines are safe and effective in children aged six years and younger. |
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06/13/2022
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Comments Extended on Antimicrobial Drug Use
[75 Words]
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| Federal Register notice: FDA extends the comment period for a 2/16 notice that requested comments on antimicrobial drug use practices in companion animals and impacts on antimicrobial resistance. |
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06/13/2022
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Science Advisory Board Renewal
[55 Words]
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| Federal Register notice: FDA renews its Science Advisory Board to the National Center for Toxicological Research for an additional two years. |
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06/13/2022
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FDA Hits Rentschler Biopharma with 9-item 483
[2640 Words]
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| A February inspection at Rentschler Biopharma’s German drug substance manufacturing plant results in a nine-item FDA-483 that cites significant GMP violations. |
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06/13/2022
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Health Canada OKs ALS Drug Delayed at FDA
[371 Words]
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| While FDA extends its own NDA review, Health Canada approves Amylyx Pharmaceuticals Albrioza (sodium phenylbutyrate and ursodoxicoltaurine) for treating amyotrophic lateral sclerosis (Lou Gehrig’s Disease). |
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06/13/2022
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Homology Clinical Hold on Gene Therapy Lifted
[207 Words]
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| FDA removes a clinical hold on Homology Medicines and its pheNIX gene therapy clinical trial evaluating HMI-102 in adults with phenylketonuria after changes are made to clinical protocol. |
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06/13/2022
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Lilly’s Olumiant Approved for Alopecia
[2839 Words]
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| FDA approves an Eli Lilly supplemental NDA for Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia areata. |
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06/13/2022
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