FDA Updates Refuse-to-Receive Rules for ANDA Submissions

The FDA has updated its guidance on refuse-to-receive criteria for ANDAs to include a reference to the Office of Pharmaceutical Quality, which didn’t exist when the guidance was finalized.

The guidance, which was introduced as a draft in September 2013 and finalized last year, defines major and minor deficiencies that would lead to the agency refusing to receive generic drug submissions. It also lays out the process and timeframe required for generic drugmakers to fix deficiencies.

ANDAs that have one major deficiency will automatically be refused, while it takes 10 or more minor deficiencies to derail an application. If a sponsor decides to correct the deficiencies and resubmit the application, it will be considered a new ANDA and require a new GDUFA fee.

Major deficiencies include failure to file a complete or proper form, failure to file a complete environmental assessment and failure to provide proof that each nonclinical and clinical study was conducted properly.

Minor deficiencies include incomplete facility information in an ANDA, improper patient certification and improper proposed labeling. Applicants with fewer than 10 minor deficiencies can opt to correct the ANDA within seven calendar days of being notified by the FDA. If accepted, the agency will consider it received on the date of the original submission and the applicant will not be required to pay a new GDUFA fee.

In addition to referencing OPQ, the FDA removed a paragraph on active pharmaceutical ingredient with a Type 2 API drug master file reference, incorporating that information into a paragraph on starting materials.

View the revised guidance at www.fdanews.com/05-27-15-refuse-to-receive.pdf. — John Bechtel