Amarin Corp Plc (AMRN)

[Toddrobertking]

“The FDA will continue to ensure that any scientific and regulatory issues raised in a petition are considered prior to the product approval, as citizens petitions can raise relevant concerns.”

This above is a quote from the FDA’s new guidance released on Sept 18: “FDA In Brief: FDA issues final guidance to address ‘gaming’ by the use of citizen petitions”

The guidance does go on to say:

“The guidance describes the FDA’s current thinking on what constitutes a 505(q) petition and some of the factors the agency will consider in determining whether a petition is submitted with the primary purpose of delaying the approval of a drug application. If the agency determines that this is the case, the FDA will consider whether the petition can be denied on that basis and may in any case note this determination in the petition response, which is posted publicly. The agency believes this will provide an additional deterrent to pursuing these tactics. By addressing challenges associated with this type of petition, the FDA aims to improve the efficiency and predictability of the drug review process and to help to drive down the costs of drug development.”

Full guidance can be found here:

https://www.fda.gov/news-events/fda-brief/fda-brief-fda-issues-final-guidance-address-gaming-use-citizen-petitions