During the course, students will examine the process to request a meeting with the FDA, specifically to discuss the phase 3 development of a drug or biologic product (termed an end-of-phase 2 meeting). Following a review of the guidance and expectations, students will be requested to prepare a meeting request and cover letter according to the guidelines and prepare draft high-level questions for the FDA to answer using as an example the drug or biologic product

In completing Written Assignment #2 for the course, students will have the opportunity to assimilate what they have learned about the development of a drug or biologic product by examining, analyzing and compiling an official end of phase 2 meeting request. Successful completion of this exercise will require students to communicate an understanding of the expectations for phase 3 and the BLA submission contents as a whole, as well as to clearly analyze and describe what a company needs to know at the time they embark on a phase 3 program for a drug or biologic product.

Things to remember:
This assignment is not meant to be complicated

BE CREATIVE!
It is important for the agency to make a quick decisions about whether the filing category is correct and which organization should be involved in the review of the marketing application.

Possible fictional issues you may want to address at your meeting: (please only use two)

Review status – priority, accelerated, standard

Potential advisory committee – which one, timing

Content of submission – CTD format vs. other, electronic vs. paper

Presentation format of data – tables, listings, graphs

Discussions of any changes in the Phase 3 studies and analysis

Presentation of safety and efficacy data and analysis

Presentation of CMC – data, validation, batch records

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