International Journal Of Drug Regulatory Affairs

Table of Contents

• REVIEW ARTICLE

  Regulatory procedures for emergency approval of medical products by regulatory agencies

  • Author: G HariCharan, Kishore Kumar Ramoju, S Suhana, Yamini Lindait
  • DOI: 10.22270/ijdra.v9i2.459

• FDA's drug regulatory pathways, its development strategies and regulatory considerations

  • Author: Iva Dhulia, Himani Patel, Narendra Chauhan, Nidhi Pardeshi
  • DOI: 10.22270/ijdra.v9i2.460

• Regulatory aspects for competitive Generic Therapies in USA

  • Author: Himani Patel, Iva Dhulia, Umesh Dobariya, Nidhi Pardeshi, Yogesh Katariya
  • DOI: 10.22270/ijdra.v9i2.463

• Interview Questions on ANDA filing

  • Author: Rajkumar Gupta
  • DOI: 10.22270/ijdra.v9i2.464

• Overview on Biopharmaceutics Classification System (BCS) based biowaiver requirements in African countries

  • Author: Nidhi Sagar Pardeshi, Iva Dhulia, Himani Patel, Umesh Dobariya, Sandip Sarvaiya
  • DOI: 10.22270/ijdra.v9i2.465

• Current regulations for Herbal Medicines in India

  • Author: Saloni Singh, Vikesh Kumar Shukla
  • DOI: 10.22270/ijdra.v9i2.466

• Registration Process of Medical Devices in CIS Countries

  • Author: Ayesha Bi Shaik, G. Ramakrishna
  • DOI: 10.22270/ijdra.v9i2.468

• Strategic Intellectual Property Management and spin offs during Medical Device Innovation and commercialisation

  • Author: Suchita Markan
  • DOI: 10.22270/ijdra.v9i2.469

• Regulatory advances and prospects of variation filing for the registered parenteral products in USA and Europe

  • Author: Rajdeep G. Makwana, Kuldeep V. Desai, Vaibhav Kikani, Maulikkumar D. Vaja
  • DOI: 10.22270/ijdra.v9i2.470

• Indian Active Pharmaceutical Ingredient (API) Industry- An overview on Challenges, Opportunities & Regulatory prerequisites

  • Author: Shefali Singh, Harvinder Popli
  • DOI: 10.22270/ijdra.v9i2.471

• Nitrosamine Impurities: Origin, Control and Regulatory Recommendations

  • Author: Umesh Dobariya, Narendra Chauhan, Himani Patel, Nidhi Pardeshi
  • DOI: 10.22270/ijdra.v9i2.472

• Liposome Characterization, Applications and Regulatory landscape in US

  • Author: Amit Kumar, Madhu Gupta, Simran Braya
  • DOI: 10.22270/ijdra.v9i2.474