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April - June 2023 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
April - June 2023 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reportin...
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Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing
Clinical Pharmacology
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FDA/PQRI Workshop on the Regulatory Framework for the Utilization of Artificial Intelligence in Pharmaceutical Manufacturing - 09/26/2023
This FDA/PQRI Workshop will bring together leaders from regulatory agencies, industry, and academia to discuss critical to...
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Gulf States International, Inc. - 666918 - 09/12/2023
Refusal to Provide Access to and Copying of Records
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Zhao Qing Longda Biotechnology Co. Ltd. - 664934 - 09/18/2023
Refusal to Provide Access to and Copying of Records
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Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications
Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications
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Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Prod...
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FDA issues guidance on using remote oversight tools to help approve drugs
FDA issues guidance on using remote oversight tools to help approve drugs
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Dr. Paul's Lab - 612964 - 02/16/2021
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
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