7.5.4 Customer property: The manufacturer shall exercise care with customer property while it is under the manufacturer's control or being used by the manufacturer. The manufacturer shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall ...

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 ...