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Consumer Groups Sought for Advisory Panels

[ Price : $8.95]

Federal Register notice: FDA asks that consumer organizations notify the agency if they are interested in participating in selecti...

Guide on Metabolism Inborn Errors

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Federal Register notice: FDA makes available a revised draft guidance entitled Inborn Errors of Metabolism That Use Dietary Manage...

BeiGene sNDA for Brukinsa in Lymphoma

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FDA accepts a BeiGene supplemental NDA for Brukinsa (zanubrutinib) in combination with obinutuzumab for treating adult patients wi...

Notice Correction on CDISC Study Data Tabulation

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Federal Register notice: FDA corrects an 8/20 notice to reflect the correct dates that the support and requirement were to begin f...

Guide on What Constitutes an Inspection Delay/Refusal

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Federal Register notice: FDA makes available a draft guidance entitled Circumstances that Constitute Delaying, Denying, Limiting, ...

Updated CVM Guide on Antimicrobial Resistance Risks

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FDA issues a draft update to guidance for industry #152, Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Th...

Providence Medical Tech Cavux Facet Device Cleared

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FDA clears a Providence Medical Technology Cavux Facet Fixation System (FFS) for spinal surgery patients requiring a revision for ...

Cytalux Approved for Lung Cancer Lesion Detection

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FDA approves an On Target Laboratories supplemental NDA for Cytalux (pafolacianine) to help surgeons in identifying lung cancer le...

FDA OKs Ferrings Bladder Cancer Gene Therapy

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FDA approves a Ferring Pharmaceuticals BLA for Adstiladrin (nadofaragene firadenovec-vncg), a non-replicating adenoviral vector...

Panel to Examine Ongoing Covid Vaccine Modifications

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FDA says it is holding a 1/26/2023 meeting of its Vaccines and Related Biological Products Advisory Committee to consider whether ...