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Cross Labeling Oncology Drugs in Combination Regimens
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227
FDA
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Omega & Delta Co., Inc. - 636606 - 11/02/2022
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278
FDA
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Abraxis Bioscience LLC - 633713 - 10/31/2022
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249
FDA
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M10 Bioanalytical Method Validation and Study Sample Analysis
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223
FDA
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Clinical Trial Basics
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237
FDA
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Adam’s Polishes, LLC Issues Voluntary Nationwide Recall of Hand Sanitizer Due to Potential Contamination With Methanol
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388
FDA
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The Key Elements of Being “Recall-Ready”
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459
FDA
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FDA Updates on Bebtelovimab
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234
FDA
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The Key Elements of Being “Recall-Ready” | Audio Transcript
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456
FDA
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The ABCs of Product-Specific Guidances | Audio Transcript
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322
FDA
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Transcript: "Abbreviated Approval Pathways for Drug Product: 505(b)(2) or ANDA?" September 19, 2019 Issue
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328
FDA
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Transcript: "Improving Regulatory Communication via the CDER NextGen Portal" December 19, 2019 Issue
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354
FDA
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FDA Modernizes Clinical Trials with Master Protocols | Transcript
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270
FDA
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Transcript: "Competitive Generic Therapies" May 23, 2019 Issue
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282
FDA
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Transcript: "Research Investigational New Drug Applications – What You Need To Know"
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437
FDA
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Recently Issued Guidance Documents
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345
FDA
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Regulatory update - EMA encourages companies to submit type I variations for 2022 by end of November, , 03/11/2022
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524
EMA
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Acetaminophen
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418
FDA
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Alternative Health Distribution LLC d/b/a CannaAid - 641241 - 11/01/2022
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412
FDA
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Remarks by FDA Commissioner Robert Califf to the 2022 Inter-governmental Working Meeting on Drug Compounding - 11/01/2022
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479
FDA
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