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Status Updates for ANDAs: FDA Spells Out GDUFA II Provision

Posted 06 October 2017 | By Zachary Brennan 

Status Updates for ANDAs: FDA Spells Out GDUFA II Provision

Under the second iteration of the Generic Drug User Fee Act (GDUFA II), the US Food and Drug Administration (FDA) has agreed to provide timely abbreviated new drug application (ANDA) review status updates for all pending ANDAs.

The updates for applicants on their ANDA review status will include the issuance of Information Requests (IRs) and Discipline Review Letters (DRLs), and to provide applicants with an advance notification of regulatory correspondence, including Refuse-to-Receive Letters, Filing Acknowledgement Letters, Complete Response Letters, Approval Letters and Tentative Approval Letters, the agency said in a new MAPP published Friday.

The MAPP comes after a busy week for FDA's Office of Generic Drugs (OGD), which held a two-day meeting on modernizing generic drug development, launched an online portal for industry requests on pre-ANDA meetings for complex generics, and released guidance on prior approval supplements, completeness assessments for Type II active pharmaceutical ingredient drug master files, refuse-to-receive standards, amendments to ANDAs, formal meetings between FDA and ANDA applicants and ANDAs for certain peptide drug products.


According to the manual published Friday, if a company's Authorized Representative raises concerns or seeks additional information on correspondence sent to an applicant during the filing review identifying nine or fewer minor filing deficiencies to be addressed before the ANDA can be considered substantially complete for review, FDA managers are told to "remind the Authorized Representative that they are providing advance informal notice as a courtesy and encourage the Authorized Representative to review the actual Filing IR upon receipt."

The MAPP notes that OGD project managers will respond to inquiries from Authorized Representatives within two business days of receipt.

It also notes that Authorized Representatives will be encouraged "to be vigilant about their ongoing obligations with respect to received submissions. For example, the OGD RPM [regulatory project manager] should encourage the Authorized Representative to ensure that all facilities are ready for inspection; that applications are updated in a timely manner to address labeling changes, product-specific guidances, or compendial changes; and administrative amendments (such as amendments concerning the impending expiration of a blocking patent or the favorable conclusion of patent litigation) are submitted in a timely manner."

Authorized Representatives will also be advised if a major deficiency is identified during a preliminary FDA review that a formal communication will likely be forthcoming.

Manual of Policies and Procedures: Communicating Abbreviated New Drug Application Review Status Updates with Industry

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