Regulatory frameworks and filing discrepancies in generic drug approvals: A cross-regional study with analysis of FDA ANDA deficiencies
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J Pawar, N Hegde, S Sharma
Annales Pharmaceutiques Françaises, 2025
Elsevier
Objectives This research aims to analyse the regulatory frameworks for generic drug applications in the US, EU, India, Japan, and China comparing their filing requirements to identify gaps and areas for harmonization. Additionally, it focuses on examining common deficiencies in ANDA from FDA submissions in 2014–2023 to address issues, facilitating more efficient approvals and minimizing delays. Material and methods The research involved analysing regulatory documents available on official websites, including the FDA …
