International Journal Of Drug Regulatory Affairs

Table of Contents

• REVIEW ARTICLE

  The BIOSECURE Act: Key implications for U.S. Biotechnology, National security, and Federal funding

  • Author: Bobby George
  • DOI: 10.22270/ijdra.v14i1.840

• Between Statutes and Practice: Regulatory Capacity for Clinical Trials in The Gambia within the ECOWAS Regional Context

  • Author: Abdoulie Bojang
  • DOI: 10.22270/ijdra.v14i1.843

• Comprehensive Comparison of Clinical Trial Protocol & Clinical Investigation Plan in Different Countries

  • Author: Chaitanya Sedamaki, Hara Naga Ganesh Dhulipudi, Rudra Vaishno, D. Prasanthi
  • DOI: 10.22270/ijdra.v14i1.844

• Regulation of the Pharmaceutical Industry in Côte d'Ivoire and alignment with community development policies: realities and prospects for 2025

  • Author: Anne-Cinthia Amonkou-N’guessana, Paule Mireille Alloukou-Bokaa, Fatima Guiet Matic, Aziz Flores Dominique Kamelana, Franck Habib Gauzea, Antoine Serge Amari
  • DOI: 10.22270/ijdra.v14i1.848

• Global Regulatory Frameworks for Drug Approval: A Comparative Review of USFDA, EMA, and CDSCO

  • Author: Anand Mane, Sudarshan Nagrale
  • DOI: 10.22270/ijdra.v14i1.852

• Electronic Common Technical Document (eCTD): Structure, Submission Process, and Regulatory Updates

  • Author: Pravin Salunkhe, Sudarshan Nagrale
  • DOI: 10.22270/ijdra.v14i1.854

• Regulatory Affairs in Clinical Trials: Ethical, Legal, and Compliance Considerations

  • Author: Rutuja Vijaykumar Pradnyawant, Sudarshan Nagrale
  • DOI: 10.22270/ijdra.v14i1.857

• Pharmaceutical Regulatory Intelligence: Tools, Strategies, and Impact on Product Lifecycle Management

  • Author: Sonam Shamrao Nimbalkar, Sudarshan Nagrale
  • DOI: 10.22270/ijdra.v14i1.858

• Reinventing Drug Development and Regulatory Affairs through Artificial Intelligence

  • Author: Almas Nafis Shaikh, Shoaib Ali Syed
  • DOI: 10.22270/ijdra.v14i1.860

• Regulatory Requirements for Participation in WHO Prequalification Programme for Parenteral Products

  • Author: Aditi Muskan Jha, Maitrey Zaveri, Shirish Patel, Zuki Patel
  • DOI: 10.22270/ijdra.v14i1.864

• Bridging Regulatory Speed: A US–EU Perspective on Rapid Drug Approvals

  • Author: Nidhi Anilsingh Bhadauria, Maitreyi Zaveri, Shirish Patel, Zuki Patel
  • DOI: 10.22270/ijdra.v14i1.872