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Priority Generic Drug Reviews: New FDA Draft Guidance


In preparation of its commitments under the second Generic Drug User Fee Amendments (GDUFA II), the US Food and Drug Administration (FDA) on Monday released a draft guidance laying out how sponsors can qualify for shorter review times for priority generic drugs.

Under GDUFA II, FDA agreed to shorten its review of eligible priority generics by two months if sponsors submit a complete and accurate pre-submission facility correspondence (PFC) two months ahead of their abbreviated new drug application (ANDA), prior approval supplement (PAS) or amendment.

"This critical 2-month lead time provides the agency the opportunity to determine whether facility inspections will be needed, and, when they are, to initiate inspection planning earlier in the review of the ANDA, enabling FDA to meet the shorter review timeframe," FDA writes.

In the draft guidance, FDA details the information and format it says sponsors must include in their PFCs, which includes:

  1. General information, including the planned ANDA pre-assignment number (which the applicant must request from FDA before submitting the PFC), PFC submission date, and the applicant's identifying information;
  2. Statement of ANDA eligibility for priority review;
  3. Manufacturing process and testing facility information; and
  4. Bioequivalence summary and site/organization information.

To attest that an ANDA is eligible for priority review, FDA says sponsors must include a statement detailing which criteria for priority review the submission meets, pointing sponsors to its Manual of Policies and Procedures (MAPP) on ANDA prioritization.

Under the MAPP, FDA lays out eight criteria that may qualify an ANDA for an expedited review, such as applications for sole-source generics, products in shortage, first generics and generics that could help address public health emergencies.

However, FDA cautions sponsors to ensure they get everything right in the PFC the first time around, or else risk receiving a standard review timeframe.

"Absent extraordinary circumstances, FDA does not expect to utilize its limited resources to review a second PFC on the same submission if the first one is deficient," FDA writes.

The agency also says that PFCs must be submitted between two and three months before the planned ANDA submission, as submitting the PFC less than two months would give the agency too little time to assess the information and more than three months ahead would put the information at risk for being out-of-date.