The following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the BPCA and pediatric assessments conducted under PREA.
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October 10, 2024: Meeting of the Cardiovascular and Renal Drugs Advisory Committee – 10/10/2024
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Cohance Lifesciences Limited – 8/12/2025. Country: India. Record Type: 483UPDATED MEETING DATE AND PUBLIC PARTICIPATION INFORMATION: May 5, 2025 Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement – 05/05/2025
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CGMP/Finished Pharmaceuticals/Adulterated