New FDA Approach for Feedback on Applications for a Marketing Authorisation (NDA/ ANDA)

The former system with the 3 different kinds of feedback possibilities from the FDA to a submitted application for a marketing authorisation (NDA/ANDA):

  • "approval": approval for marketing in the USA
  • "approvable": approval probably possible after submission of additional information or after certain alterations
  • "not approvable": approval shows deficiencies that make the transmission of extensive additional information necessary

was not always consistent regarding the two latter items.

On 11 August 2009, these two were replaced by the "Complete Response Letter" at the end of the review period. This letter is meant to specify existing deficiencies and, where possible, to give recommendations, without making statements on the probability of a final approval through the former classification.

The new approach serves to improve and standardise communication between authority and applicant. The new system will correspond to the approach used for biological products. Here, "Complete Response Letter" has been issued already since 1998.

Further information can be found here.

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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