Question12: You are hired as a consultant by a company which is starting to manufacture a new remedy entirely based on products extracted from garlic. Would you suggest to file NDA with FDA (in USA ) or TPD (in Canada )? Support your answer with appropriate reasoning?

Apr 7 • Clinical Research Associate, Clinical trail, CRA certification, cracertification_Q&A, cracertification.co.uk • 2385 Views • Comments

Question12: You are hired as a consultant by a company which is starting to manufacture a new remedy entirely based on products extracted from garlic. Would you suggest to file NDA with FDA (in USA ) or TPD (in Canada )? Support your answer with appropriate reasoning?

Answer:

As a Consultant I would not prescribe or recommend herbal remedies without well-established efficacy because with Herbal medicines, In some cases, it is unclear which constituents produce the therapeutic effect. Testing for efficacy in this situation is obviously more complex than with synthetic drugs. Unfortunately, systematic reviews are often limited by the paucity and varied methodological quality of the primary studies, andresearch funds are generally scarce, in part because plants cannot be patented

Therefore usually complete data are NOT available from the manufacturer for the safety or effectiveness of these products.

If  the drug really works for the particular disease condition with  a minimal toxicity level and if I am sure that the answer is a definite YES then only I recommend to file NDA with FDA otherwise not.

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