BTRA 643 University of Maryland University College Practical Application of Biotech Paper

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Throughout the course students will examine the process of submitting Marketing Applications to the US Food and Drug Administration (FDA) to request authorization to commercialize a medical product.  Through the course we will review examples of marketing applications 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 medical 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 this Written Assignment for the course, students will have the opportunity to assimilate what they have learned by examining, analyzing and compiling an official supplement cover letter using a same product of your choice.

Purpose of the request:

FDA is urging you the sponsor to file a BLA/NDA 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:

New or renovated facilities

New technologies used

New approaches to product development
Container closure integrity testing

Please choose 1.

Things to remember:
This assignment is not meant to be complicated; you are completing a cover letter to the agency.
This assignment only requires the cover letter, which should clearly highlight the significant changes and their scope to expedite the agency review and approval process.  BE CREATIVE!
The cover letter serves as the basis for determining which reviewer should be involved.
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 supplement – for example, a product specialist or facility CMC reviewer. 

2)Ensuring the safety, effectiveness, and quality of human drugs is an increasingly complicated regulatory task, requiring FDA experts to consider a multitude of complex factors. Over the past several years, the FDA has developed an enhanced, structured approach to benefit-risk assessment in regulatory decision-making for human drug and biologic products. Review the attached document then answer the following questions.Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-MakingWhat are your thoughts on the new framework? Will this framework help the FDA to assess its risk-benefit decision making as it relates to disease areas where treatment options are less than optimal? Will the framework provide value to internal reviewer communications and discussions related to premarket regulatory decisions? 

3) What do you think of Japan’s three-pillar system and the idea of relief as a part of a medical products regulatory body? 

4) What do you think of the “new” Japanese MAH framework? Is it just the same as the old ICC framework, or is it actually a step in a different direction?

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