FDA publishes post CRL guidance for generic companies

The US Food and Drug Administration (FDA) has published final guidance for the generics industry on post-complete response letter (CRL) meetings.

Such meetings take place between the FDA and generic drug companies to clarify deficiencies identified in a CRL 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The FDA has revised the draft guidance on this matter to provide clarifying information on the process for submitting post-CRL meeting requests and the criteria for granting such requests.