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TXT Former FDA Commissioner Frank Young Dies at 88 [329 Words] [ Price : $8.95]
Former FDA commissioner Frank Young dies at age 88.
11/27/2019
 
 
TXT Tzvi Lexiere Debarred for 10 Years [81 Words] [ Price : $8.95]
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.
11/27/2019
 
 
TXT Six ANDAs Withdrawn by FDA [56 Words] [ Price : $8.95]
FDA withdraws approval of six ANDAs from multiple applicants after they notified the agency that the drug products were no longer marketed.
11/27/2019
 
 
TXT Draft Guide on Biosimilar Clinical Immunogenicity [100 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled “Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products.”
11/27/2019
 
 
TXT FDA Approves QuantiFeron-TB Plus Diagnostic [166 Words] [ Price : $8.95]
FDA approves a Qiagen and DiaSorin PMA for the automated workflow for QuantiFeron-TB Plus, a fourth-generation test for latent tuberculosis detection.
11/27/2019
 
 
TXT Zebra Medical 510(k) Cleared for HealthCXR [94 Words] [ Price : $8.95]
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.
11/27/2019
 
 
TXT B. Braun Recalls Blood Administration Sets [2682 Words] [ Price : $8.95]
FDA says B. Braun is recalling 43,026 blood administration sets that may leak at the joint between blood filters and tubing.
11/27/2019
 
 
TXT Man Indicted for Illegal Animal Drug [2664 Words] [ Price : $8.95]
A Puerto Rico federal grand jury indicts an individual on charges relating to shipments of an illegal, adulterated, and misbranded animal drug.
11/27/2019
 
 
TXT FDA Initial Steps on CBD Explained [2802 Words] [ Price : $8.95]
Mintz attorney Joanna Hawana explains FDA’s position of regulating cannabis-derived products as shown in recent public announcements.
11/27/2019
 
 
TXT FDA Denies US WorldMeds Apokyn Petition [2736 Words] [ Price : $8.95]
Citing time restrictions, FDA denies without comment a US WorldMeds petition asking for specific treatment of any ANDA citing its Apokyn.
11/27/2019
 
 
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