What is the typical research and regulatory testing pathway for new products?

Categories: Gene Drive Mosquitoes, Risk Analysis

Before a new vector control product is brought to market, it is standardly tested in a series of expanding clinical or field trials. This phased testing pathway allows developers and regulators to learn whether the new product works and is safe to use. Research on new products begins with extensive testing in the laboratory. Developers will submit laboratory results to regulatory authorities, who will determine whether and how the product can move to clinical or field testing. Upon regulatory approval, testing will begin at a very small scale under conditions that minimize risk to people or the environment. If results from such small-scale testing look promising, regulators may approve moving to larger scale trials of safety and efficacy. Based on those results, regulators will decide whether and under what conditions the product can be made publicly available. If at any phase of the pathway the product fails to demonstrate agreed upon safety and efficacy characteristics it should not move forward, and developers will need to decide whether and how it might be improved to restart the testing process.

For more information:

https://www.fda.gov/patients/drug-development-process/step-3-clinical-research
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/what-clinical-trials-are/phases-of-clinical-trials
https://apps.who.int/iris/bitstream/handle/10665/259688/WHO-HTM-NTD-VEM-2017.03-eng.pdf

https://nap.nationalacademies.org/catalog/23405/gene-drives-on-the-horizon-advancing-science-navigating-uncertainty-and

Did you find this FAQ helpful?
0
0

Leave a Reply

Your email address will not be published.