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International Journal of Drug Regulatory Affairs
Year 2024, Volume-12, Issue-3 (September)
Print ISSN: 2321-7162
Online ISSN: 2321-6794

Table of Contents

Research Article

The Co-Sponsor in the conduct of a Clinical Trial in Germany
Raees Ahmed, Simge Süngü, Christoph Gerst

Review Articles

Post-approval changes in Labelling regulations in the United States, European Union and Canada
Yash Shegokar, Sakshi Dhawad, Vinita Kale, Suankit Harane, Milind Umekar

Medical Foods for the management of Chronic Illness and their Regulations in India, US and European Union
Trapti Saxena, Sruthi Yadala, Ausali Kavya Sri, Pishati Manasa Reddy, Monika Nijhawan

Comparative evaluation of Food for Special Dietary Use (FSDU) and Food for Special Medical Purpose (FSMP) product regulatory framework in India, EU and US
Aashvi Patel, Maitreyi Zaveri, Vishal Dubey, Dharmesh Kheni, Niranjan Kanaki

A Review on a Drug Registration Process in United Kingdom
Yash B. Kulkarni, Lokesh P. Kothari

Regulatory Development, Adoption, and Perseverance of Real-world Evidence with global health authorities
Sanyam Gandhi, Kinshuk Saxena, C Kartikeyan, Akhilesh Tiwari, Sachin Jain, Vikas Jain, Pradeep Pal

Lifecycle Management of Generic product in US market
Sakshi Dhawad, Samiksha Dhote, Yash Shegokar, Vinita Kale, Milind Umekar

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

Navigating Regulatory requirements for Stem Cells Therapy- A review on Regulations of US, European Union, Japan and India
Aishwarya M Khabade, Shruti S Agarwal, Harshali B Mahajan, Satish K Mandlik

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