International Journal Of Drug Regulatory Affairs

Table of Contents

• RESEARCH ARTICLE

  The Co-Sponsor in the conduct of a Clinical Trial in Germany

  • Author: Raees Ahmed, Simge Süngü, Christoph Gerst
  • DOI: 10.22270/ijdra.v12i3.666

• REVIEW ARTICLE

  Post-approval changes in Labelling regulations in the United States, European Union and Canada

  • Author: Yash Shegokar, Sakshi Dhawad, Vinita Kale, Suankit Harane, Milind Umekar
  • DOI: 10.22270/ijdra.v12i3.680

• Medical Foods for the management of Chronic Illness and their Regulations in India, US and European Union

  • Author: Trapti Saxena, Sruthi Yadala, Ausali Kavya Sri, Pishati Manasa Reddy, Monika Nijhawan
  • DOI: 10.22270/ijdra.v12i3.684

• Comparative evaluation of Food for Special Dietary Use (FSDU) and Food for Special Medical Purpose (FSMP) product regulatory framework in India, EU and US

  • Author: Aashvi Patel, Maitreyi Zaveri, Vishal Dubey, Dharmesh Kheni, Niranjan Kanaki
  • DOI: 10.22270/ijdra.v12i3.687

• A Review on a Drug Registration Process in United Kingdom

  • Author: Yash B. Kulkarni, Lokesh P. Kothari
  • DOI: 10.22270/ijdra.v12i3.691

• Regulatory Development, Adoption, and Perseverance of Real-world Evidence with global health authorities

  • Author: Sanyam Gandhi, Kinshuk Saxena, C Kartikeyan, Akhilesh Tiwari, Sachin Jain, Vikas Jain, Pradeep Pal
  • DOI: 10.22270/ijdra.v12i3.692

• Lifecycle Management of Generic product in US market

  • Author: Sakshi Dhawad, Samiksha Dhote, Yash Shegokar, Vinita Kale, Milind Umekar
  • DOI: 10.22270/ijdra.v12i3.693

• Index of application status transparency and availability of public information for Project Orbis agencies

  • Author: Sso H. Lee, Lauren T. Hotaki, Kukhwa Oh, Jessica Samuel, Krystal de Villiers, Kirubel Eshetie, Yee H. Looi, Eiman Atiek, Fanny Cudré-Mauroux, Ulrich-Peter Rohr, Graham Searle, Lenardo N. Santos, Silmara Andreoli, Yoko Aoi, Masakazu Hirata, Caroline Voltz-Girolt, Carlos Aicardo, Callan Cain, Tal Naggan, Anat Boehm-Cagan, Michal Hirsch-Vexberg, Osnat Luxenburg, Nabbiya Ahmed, Laura Johnson, Melissa Hunt, Duc Vu, Marc R. Theoret, Dianne Spillman, R Angelo Claro
  • DOI: 10.22270/ijdra.v12i3.699

• Navigating Regulatory requirements for Stem Cells Therapy- A review on Regulations of US, European Union, Japan and India

  • Author: Aishwarya M Khabade, Shruti S Agarwal, Harshali B Mahajan, Satish K Mandlik
  • DOI: 10.22270/ijdra.v12i3.704