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K FEEDBACK FORM INSIDE Peace River Site C Hydro Project A n o p t i o n to h e l p c lo s e B. C. s g r o w i n g e l e c t r i c i t y g a p P r e C o n s stat at i o n D i s c u SS i o n G u i d

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What is pre-consultation discussion guide amp?

The pre-consultation discussion guide amp is a document that outlines the topics and questions to be discussed during a pre-consultation meeting in regard to an amp (authorization for marketing product). It serves as a roadmap for planning and organizing the discussion.

Who is required to file pre-consultation discussion guide amp?

The pharmaceutical company or applicant seeking authorization for marketing a product is required to file the pre-consultation discussion guide amp.

How to fill out pre-consultation discussion guide amp?

The pre-consultation discussion guide amp can be filled out by providing answers to the specific topics and questions mentioned in the document. It may include information about the product, its development, proposed labeling, clinical trials, safety data, and any concerns or questions for discussion during the pre-consultation meeting.

What is the purpose of pre-consultation discussion guide amp?

The purpose of the pre-consultation discussion guide amp is to facilitate effective communication and exchange of information between the pharmaceutical company/applicant and the regulatory authority. It allows both parties to have a structured discussion about the product, its development, clinical data, safety profile, labeling, and any other relevant aspects before the formal submission of an amp application.

What information must be reported on pre-consultation discussion guide amp?

The pre-consultation discussion guide amp may require information such as product name, proposed indication, formulation, dosing, safety data, clinical trial results, proposed labeling and packaging, potential risks or concerns, and any specific questions for discussion during the pre-consultation meeting. The exact information to be reported may vary based on regulatory requirements and specific product characteristics.

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