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International Journal Of Drug Regulatory Affairs
Year 2024, Volume-12, Issue-4 (December)
Print ISSN : 2321-7162
Online ISSN : 2321-6794

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Review Article

FDA 510(k) submission insights for syringes
Akash Sharma, Chandra Prakash, Ankur Vora, Harsh Mehta

Research Article

An impact assessment of post-approval regulatory and quality compliance at a UK - Only pharmaceutical manufacturer
Melissa Brimelow, Kevin G M Taylor, Satyanarayana Somavarapu, Umamaheswari Cherukuri, Ronald Akinwale, Khalid Ahmad Sheikh

Review Articles

Comprehensive cosmetic regulations comparison of selected emerging markets with US
Nandini Rebbaniboni, Divya Amarapalli, Ayesha Parveen, Prasanthi D.

A review on artificial intelligence and machine learning in a medical device
Durgesh V. Patil, Ganesh D. Basarkar

Artificial intelligence and machine learning: Enhancing the future of regulatory affairs
Lokesh Kumar Boopathi, Nandhini Raja

Current regulatory framework of digital health in India
Ridhima Sandal, Sonal Setya

Coordinating research and evidence for medical devices (CORE MD) and beyond
Zuveria Anjuman, Tigulla Srichakritha, Prasanthi D.

Comparison of GMP for drugs in EU, US, Canada, WHO and Australia
Akshda Patil, Medha Devidas Kuchal, Prasanthi D.

Quality audits in medical device manufacturing: Best practices and challenges
Revathi Korupolu

Recall of drug in India and United Kingdom: A comparative review
Prasad Sanjay Pangavhane, Sayali Pandurang Shinde, Sakshi Balkrishna Bhusal

Research Article

The role of paraprobiotics in breast cancer cell line (MCF-7): In vitro study
Gulcin Alp Avcia, Emre Avci

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