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What stage of product development occurs before the developer submits a product for regulatory assessment of approval for its commercial sale?

O A. Pre market
OB. Submitted/pre market
O C. Post market
O D. At market

2 Answers

7 votes

Answer:D. At market

Step-by-step explanation:

During the pre-market stage, the developer conducts research and development, performs preclinical and clinical trials (if applicable), gathers data on the product's safety and efficacy, and prepares the necessary documentation to support the submission for regulatory assessment. This stage involves activities such as formulation development, manufacturing scale-up, quality control testing, and establishing the product's safety and effectiveness profile.

Once the pre-market stage is complete, the developer submits the product for regulatory assessment or approval, depending on the specific requirements of the regulatory authorities in the respective country or region. The regulatory assessment evaluates the product's safety, efficacy, quality, and compliance with relevant regulations and standards before granting approval for commercial sale.

Therefore, the correct answer is option A, "Pre market."

answered
User Micheal Vu
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8.3k points
5 votes
Option A: Pre market
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User Sheixt
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8.3k points