International Journal For Multidisciplinary Research

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Patient Safety and Efficacy Considerations in Abbreviated New Drug Application (ANDA) Evaluation: Balancing Access and Regulation

Author(s) Samyukta D, Senthil Kumar N, Senthil Kumar B
Country India
Abstract The Abbreviated New Drug Application (ANDA) process is pivotal in facilitating the availability of generic drugs, offering cost-effective alternatives to branded medications while ensuring patient safety and therapeutic efficacy. This review delves into the critical considerations involved in ANDA evaluation, focusing on the regulatory balance required to maintain drug quality and accessibility. Key elements such as bioequivalence, therapeutic equivalence, and compliance with Good Manufacturing Practices (GMP) are scrutinized to highlight their roles in safeguarding patient outcomes. The review also addresses the challenges posed by evolving drug formulations, manufacturing technologies, and the increasing complexity of global supply chains. Additionally, it discusses the regulatory frameworks that guide ANDA approvals, emphasizing the importance of rigorous post-marketing surveillance to detect and mitigate potential safety issues. Through an analysis of recent case studies and regulatory updates, the review identifies best practices and suggests potential areas for improvement in the ANDA process. By ensuring that generic drugs remain safe, effective, and accessible, the ANDA framework continues to play a vital role in public health.
Keywords Abbreviated New Drug Application (ANDA), bioequivalence, patient safety, therapeutic efficacy, regulatory framework, generic drugs.
Field Medical / Pharmacy
Published In Volume 6, Issue 4, July-August 2024
Published On 2024-08-17
Cite This Patient Safety and Efficacy Considerations in Abbreviated New Drug Application (ANDA) Evaluation: Balancing Access and Regulation - Samyukta D, Senthil Kumar N, Senthil Kumar B - IJFMR Volume 6, Issue 4, July-August 2024. DOI 10.36948/ijfmr.2024.v06i04.26206
DOI https://doi.org/10.36948/ijfmr.2024.v06i04.26206
Short DOI https://doi.org/gt7m5m
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