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 ...

Obtaining a regulatory license often involves an application process, fees, background checks, and compliance with specific requirements. These licenses are usually subject to periodic renewal, and failure to comply with regulations can result in fines, sanctions, or revocation of the license. The exact requirements and processes for obtaining regulatory licenses can vary significantly from one ju ...