Posted by Michael Wonder on 06 Dec 2018
FDA publishes post CRL guidance for generic companies
4 December 2018 - The US FDA has published final guidance for the generics industry on post-complete response letter meetings.
Such meetings take place between the FDA and generic drug companies to clarify deficiencies identified in a complete response letter to an abbreviated new drug application submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act.
The FDA has revised the draft guidance on this matter to provide clarifying information on the process for submitting post-complete response letter meeting requests and the criteria for granting such requests.
