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FDA Panel Shoots Down Acadia Alzheimer’s sNDA
[223 Words]
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| An FDA advisory committee votes 9-3 to not recommend approval of an Acadia Pharmaceutical resubmitted sNDA for Nuplazid (pimavanserin) for an indication to treat hallucinations and delusions associated with Alzheimer’s disease psychosis. |
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06/21/2022
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FDA Denies ICAN Covid Vaccine Petition
[141 Words]
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| FDA denies a petition from the Informed Consent Action Network asking that it not approve Covid-19 vaccines for youths ages 12-17. |
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06/21/2022
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Reform Paragraph 4 Certification Process: Analysis
[362 Words]
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| A Health Affairs analysis from West Health Policy Center suggests two reforms for the Waxman-Hatch Paragraph 4 process that could speed the entry of generic drugs into the market. |
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06/21/2022
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Draeger Recalls SafeStar 55 Breathing Filter
[164 Words]
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| Draeger recalls (Class 1) one lot of its SafeStar 55 Breathing System Filter because a manual inspection process revealed that some defective filters were inadvertently distributed instead of destroyed. |
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06/21/2022
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Paratek Pharma Fast Track for Nuzyra
[142 Words]
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| FDA grants Paratek Pharmaceuticals a fast track designation for an oral and intravenous formulation of its broad-spectrum antibiotic Nuzyra (omadacycline) for treating pulmonary nontuberculous mycobacterial disease. |
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06/21/2022
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Info Collection on Biologic Deviation Reporting
[74 Words]
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| Federal Register notice: FDA seeks comments on an information collection extension entitled “Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing; Forms FDA 3486 and 3486A.” |
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06/17/2022
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FDA Posts 3 Nanotechnology Standards for Liposomes
[85 Words]
[ Price : $8.95]
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| FDA’s National Center for Toxicological Research announces the publication of three International Test Method Standards in Nanotechnology by the American Society for Testing and Materials International, which are consensus standards for liposomes. |
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06/17/2022
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