Question

All medical products are subject to review and approval by the FDA, a process that can take Select one: a. one year b. from one to seven years c. 16 months d. from three to five years

Answer 1

Answer:

FDA takes a time span of approximately one year to review and approve a medical product.

Explanation:

To make sure that a medical product is safe to use and ready to launch in the market, FDA take a long-term process to review and approve that product. This process is mandatory to launch a product. It involves three processes to complete the procedure depending on the type of product.

The first process is, Pre-Market Approval Process, second one is the Pre-Marketing Notification Process and the third process is of The Humanitarian device exemption.

All these processes can take a maximum time span of one year and the minimum is of 3 months. However, the percentage of completing the process in 3 months is low now.

Answer 2

Answer:

b. from one to seven years

Explanation:

A series of studies and analysis needs to be done prior approval. In case of newly discovered drug - laboratory and animal studies, determination of the safety and dosage using healthy and patient volunteers, assessment of the efficient and long term effects of the drug.