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Tzvi Lexiere Debarred for 10 Years
[81 Words]
[ Price : $8.95]
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| Federal Register notice: FDA debars Tzvi Lexier for 10 years from importing any drug into the U.S. because he was convicted for conspiracy to smuggle and distribute misbranded drugs. |
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11/27/2019
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Six ANDAs Withdrawn by FDA
[56 Words]
[ Price : $8.95]
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| FDA withdraws approval of six ANDAs from multiple applicants after they notified the agency that the drug products were no longer marketed. |
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11/27/2019
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Draft Guide on Biosimilar Clinical Immunogenicity
[100 Words]
[ Price : $8.95]
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| Federal Register notice: FDA makes available a draft guidance entitled “Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products.” |
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11/27/2019
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FDA Approves QuantiFeron-TB Plus Diagnostic
[166 Words]
[ Price : $8.95]
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| FDA approves a Qiagen and DiaSorin PMA for the automated workflow for QuantiFeron-TB Plus, a fourth-generation test for latent tuberculosis detection. |
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11/27/2019
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Zebra Medical 510(k) Cleared for HealthCXR
[94 Words]
[ Price : $8.95]
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| FDA clears a Zebra Medical Vision 510(k) for its HealthCXR device intended for use in identifying and triaging pleural effusion in Chest X-rays. |
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11/27/2019
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Man Indicted for Illegal Animal Drug
[2664 Words]
[ Price : $8.95]
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| A Puerto Rico federal grand jury indicts an individual on charges relating to shipments of an illegal, adulterated, and misbranded animal drug. |
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11/27/2019
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FDA Initial Steps on CBD Explained
[2802 Words]
[ Price : $8.95]
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| Mintz attorney Joanna Hawana explains FDA’s position of regulating cannabis-derived products as shown in recent public announcements. |
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11/27/2019
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FDA Denies US WorldMeds Apokyn Petition
[2736 Words]
[ Price : $8.95]
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| Citing time restrictions, FDA denies without comment a US WorldMeds petition asking for specific treatment of any ANDA citing its Apokyn. |
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11/27/2019
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