Momenta Pharmaceuticals, Inc. (MNTA)

[floblu14]

Applicants receiving a CRL have 12 months to respond to the FDA in one of three ways under § 314.110(b)(1)-(3):

Responding to the CRL by resubmitting–
The applicant can resubmit the application in its entirety, addressing each of the deficiencies described by the FDA in the CRL, using the suggested methods offered by the FDA in the CRL, or by applying the applicant’s own solutions. The significance of the changes to the application will grant the FDA from two to six months of additional application review time.

Withdrawal–The applicant can withdraw the NDA or ANDA in its entirety. Note that such a withdrawal is without prejudice and allows the applicant to refile an application.

Request an Opportunity for a Hearing–The applicant can request the opportunity to meet with the FDA to discuss whether there are grounds for denying the application under § 505(d) and (j). However, applicants should be warned that these hearings are open and public hearings, and granting the hearing does not bind the FDA to actually reconsider the application.

http://www.healthcarelawinsights.com/2015/01/fda-complete-response-letters-the-design-v-reality-of-fdas-responses-to-drug-applications/