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What is the full form of NDA?

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What is the full form of NDA?

(a) Investigated drug

(b) Investigation Application

(c) New Drug Application

(d) Under Investigation

This question was posed to me by my school principal while I was bunking the class.

This interesting question is from Controlled Release Medication topic in chapter Controlled Release Medication of Drug Biotechnology

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The correct option is (c) New Drug Application

The explanation is: Once all the trials including phase 1, 2, 3, 4 finishes and all the reports are perfect showing that the drug can be used without any harmful effect the company submits NDA to FDA. FDA reviews NDA and takes almost about 19 months to approve the NDA. Once the NDA is approved the drug can be safely manufactured.

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