GRASTEK Cover Letter

GRASTEK Cover Letter
Order Description
• Instructions

2-3 pages

12-point font

Double spaced

Letter format (references are not required)

Throughout the course students will examine the process of submitting Biologics License Applications (BLA’s) to the US Food and Drug Administration (FDA) to request authorization to commercialize Biologics products. This week we will review examples of BLA related written communications including clinical protocols, clinical study reports, investigator brochures and packaging inserts.

As students will see, the FDA strives to maintain an application process that is rigorous enough to assess a potential Biologic product’s true risk/benefit profile. At the same time, the FDA also tries to maintain enough flexibility in the application process to account for the wide variation in Biologic product types as well as current demands in the health care system.

In completing Written Assignment #2 for the course, students will have the opportunity to assimilate what they have learned by examining, analyzing and compiling an official BLA supplement cover letter using the same product they researched for assignment 1.

Purpose of the request:

Background:

FDA is urging you the sponsor to file a Biologic License Application (BLA) supplement. As some supplements can be large, your scope should be described in the cover letter.

Below is a list of possible reasons for the supplement:

Please choose one of the reasons below.

1. New or renovated facilities
2. New technologies used
3. New approaches to product development
4. Container closure integrity testing