Develop a drug from discovery to marketing application

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Reference no: EM133838348 , Length: 15 pages

Assignment:

This Group Project requires you and your Team (no more than 3 people per Team and I do not recommend a Team of only 1) to write a 5 to 15 page (1.5 space; 1" margins around; Font Size 12 in Times New Roman; No Table of Contents) recommendation paper to a drug company, Husky Pharma.

Husky Pharm hired your Team as Consultants to advise on the regulatory pathway to develop a drug from discovery to marketing application (i.e. regulatory approval). Husky Pharma would like to know what regulatory steps should be considered and taken from discovery where the mechanism of action of a candidate drug has been identified all the way through clinical trials and marketing application in the U.S.

Hints for your paper:

Consider the nonclinical tests that may be required; what the regulatory process is to initiate clinical trials in the US; and what the regulatory process is to get a drug on the market in the US; what are the opportunities to interact with the FDA (pros and cons).

Reference no: EM133838348

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