Form CDPH52N New Drug Manufacturing License Application - California

What Is Form CDPH52N?

This is a legal form that was released by the California Department of Public Health - a government authority operating within California. As of today, no separate filing guidelines for the form are provided by the issuing department.

FAQ

Q: What is Form CDPH52N?
A: Form CDPH52N is the New Drug Manufacturing License Application for California.

Q: What is the purpose of Form CDPH52N?
A: The purpose of Form CDPH52N is to apply for a new drug manufacturing license in California.

Q: What information is required in Form CDPH52N?
A: Form CDPH52N requires information about the applicant's facility, manufacturing processes, quality control procedures, and compliance with regulatory requirements.

Q: Are there any fees associated with submitting Form CDPH52N?
A: Yes, there are fees associated with submitting Form CDPH52N. The fees vary based on the type of drug being manufactured and the size of the facility.

Q: Is a New Drug Manufacturing License required in California?
A: Yes, a New Drug Manufacturing License is required in California for the manufacturing of drugs.

Q: Who is responsible for approving or denying a New Drug Manufacturing License application?
A: The California Department of Public Health (CDPH) is responsible for approving or denying a New Drug Manufacturing License application.

Q: What happens after submitting Form CDPH52N?
A: After submitting Form CDPH52N, the application will be reviewed by the California Department of Public Health. The applicant may be contacted for additional information or inspections may be conducted.

Q: How long does it take to process a New Drug Manufacturing License application?
A: The processing time for a New Drug Manufacturing License application can vary. It may take several months to complete the review and approval process.