POLICY ON NEW DRUG APPLICATION: 1. The content of New Drug Application (NDA) should be designed by the sponsor to answer general question as follows: i. Does the new drug provide a clinical benefit? ii. Is the associated risk outweighing the benefits for the proposed indication? iii. Can the product be manufactured ensuring quality and batch to batch consistency? 2. There should be a system that b ...

POLICY ON NEW DRUG APPLICATION: 1. The content of New Drug Application (NDA) should be designed by the sponsor to answer general question as follows: i. Does the new drug provide a clinical benefit? ii. Is the associated risk outweighing the benefits for the proposed indication? iii. Can the product be manufactured ensuring quality and batch to batch consistency? 2. There should be a system that b ...

Such discussion to help the reviewers becomes acquainted with the information to be included in the NDA. 4. In case the sponsor intends to seek exemption of local clinical trial, clear request for the same should be made in the NDA alongwith rationale and justification and the relevant regulatory provision, under which the exemption is sought. 5. Similarly, in case the sponsor intends to seek app ...

THE BUREAU OF INDIAN STANDARD (BIS) Is a national standards body in India that operates under the Ministry of Consumer Affairs, Food, and Public Distribution. It plays a vital role in ensuring the quality and safety of products and services. Its main function is to formulates and promote standards to ensure the quality and reliability of products, covering a wide range of industries and sectors. I ...