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No FDA Action Against Accused Researchers
[459 Words]
[ Price : $8.95]
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| FDA denies a Public Citizen petition calling for the disqualification of two researchers at Hennepin County Medical Center, Minneapolis, MN, who “repeatedly and deliberately violated agency regulations intended to protect human subjects.” |
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05/02/2022
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Regeneron Awarded Priority Review Voucher
[84 Words]
[ Price : $8.95]
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| Federal Register notice: FDA issues Regeneron Pharmaceuticals a priority review voucher under its material threat medical countermeasure product program. |
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05/02/2022
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Marqibo Accelerated Approval Withdrawn
[111 Words]
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| Federal Register notice: FDA withdraws the accelerated approval of Acrotech Biopharma’s NDA for Marqibo (vincristine sulfate liposome injection), indicated for treating certain adult patients with Philadelphia chromosome-negative acute lymphoblastic leukemia. |
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05/02/2022
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FDA Seeks ‘Quality Process Change’ in Toripalimab BLA
[245 Words]
[ Price : $8.95]
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| FDA issues a complete response letter to Shanghai Junshi Biosciences and Coherus BioSciences on their BLA for toripalimab in combination with gemcitabine and cisplatin in patients with advanced recurrent or metastatic nasopharyngeal carcinoma, requesting a “quality process change.” |
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05/02/2022
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IND Safety Reports eSubmission Guide
[149 Words]
[ Price : $8.95]
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| FDA posts a final guidance entitled Electronic Submission of IND Safety Reports Technical Conformance Guide. |
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05/02/2022
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FDA Hold on Vertex Cell Therapy for Diabetes
[318 Words]
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| FDA places a clinical hold on a Vertex Pharmaceuticals Phase 1/2 clinical trial of VX-880, an investigational stem cell-derived, fully differentiated pancreatic islet cell replacement therapy for certain people with Type 1 diabetes. |
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05/02/2022
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Bakul Patel Leaving CDRH After 13 Years
[243 Words]
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| After 13 years at the agency, CDRH Digital Health Center of Excellence director Bakul Patel announces he will be leaving the agency early this month to explore an undisclosed new chapter in his professional life. |
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05/02/2022
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