Overview: What is a Part Submission Warrant, or PSW? A Part Submission Warrant document or form is used to confirm that the ...

These documents are essential for verifying the authenticity of the information provided, ensuring compliance with legal standards, and maintaining the integrity of the admissions process. The ...

A functional requirements document (FRD) is a document that defines the scope, objectives, features, functions, and constraints of the system from the perspective of the users and stakeholders.

For the requirements of biosimilars, sponsors should consult the Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs, when intending to file an EUND. A sponsor can ...