FDA publishes two final guidances for industry: Orange Book Questions and Answers; Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe

July 25, 2022

Alarm clock sitting on table.

July 2022

As part of FDA’s continued efforts to improve transparency and provide helpful information to regulated industry and the public, the agency is issuing two final guidances for generic drug applicants. These guidances support FDA’s Drug Competition Action Plan, which aims to increase competition in the market for prescription drugs, facilitate entry of high-quality and affordable generic drugs, and improve the public health.

Today’s publications include:

This guidance is intended to assist prospective and current drug product applicants and approved application holders in effectively using the Orange Book. The guidance provides answers to commonly asked questions FDA has received from these interested parties regarding the Orange Book and covers topics such as the content and format of the Orange Book, petitioned abbreviated new drug applications (ANDAs), the movement of drug products between the Active and Discontinued sections in the Orange Book, and drug product and patent listings. While finalizing this guidance, the agency considered comments on the draft guidance announced in the Federal Register on May 29, 2020 (82 FR 51277).

The Orange Book identifies drug products approved by FDA on the basis of safety and effectiveness under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and includes patent and exclusivity information related to those drug products. FDA has historically sought to update and enhance the Orange Book to make it more accessible and useful to regulated industry and the public.

This guidance provides information and recommendations regarding potential courses of action for an ANDA applicant after the issuance of a complete response letter (CRL) as well as the actions that FDA may take if the applicant fails to respond to a CRL. This guidance also identifies information that an applicant may submit in its request for an extension to respond to a CRL as well as a non-exhaustive list of factors that FDA generally intends to consider in determining whether such a request is reasonable. In this guidance, which finalizes the draft published in September 2020, FDA added an appendix that provides examples of factors that FDA could consider as the basis for concluding that an applicant’s request for an extension of time to respond to a CRL is reasonable.

This guidance aims to help streamline the ANDA assessment process and support FDA’s GDUFA performance commitments. FDA expects this guidance will promote efforts to address deficiencies faster, make the process for submitting and reviewing extension requests more efficient and predictable, and allow the agency to focus its resources on ANDA assessment.

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