Orange Book Questions and Answers Guidance for Industry | FDA

Orange Book Questions and Answers Guidance for Industry | FDA







FDA publishes draft guidance for industry, Orange Book Questions and Answers, and solicits feedback on use of the Orange Book and patent information listings

As part of the FDA’s continued efforts to improve transparency and provide helpful information to regulated industry and the public, we have taken several steps to make the Approved Drug Products with Therapeutic Equivalence Evaluations publication (the Orange Book) even more accessible and useful by publishing:

• A draft guidance for industry, Orange Book Questions and Answers, which is intended to assist prospective and current drug product applicants and approved application holders in effectively using the Orange Book. The draft guidance provides answers to commonly asked questions FDA has received from these interested parties regarding the Orange Book. The draft guidance covers topics such as the content and format of the Orange Book, petitioned ANDAs, the movement of drug products between the Active and Discontinued Sections in the Orange Book, and drug product and patent listings.
• A public docket to solicit comments on how stakeholders and the public use the Orange Book and whether and how it can be improved. Further information, including questions for public input, can be found in the Federal Register notice. The Agency will carefully consider all comments submitted.
• A public docket to solicit comments on the listing of patent information in the Orange Book. Stakeholders have informed FDA of the benefits of and challenges to the listing of certain types of patent information in the Orange Book, noted the omission of potentially relevant patent information, and requested clarification on whether certain types of patents fall within the scope of required patent information that must be submitted for listing in the Orange Book. In light of these and other considerations, as part of an Agency-wide effort to modernize the Orange Book, we are soliciting comments regarding the types of patent information listed in the Orange Book. Questions posed in the notice are not meant to be exhaustive and we are interested in any other pertinent information stakeholders would like to provide on the types of patent information the Orange Book should include. Further information, including questions for stakeholder input, can be found in the Federal Register notice. The Agency will carefully consider all comments submitted.

The agency is publishing this draft guidance and Federal Register notices as part of the Drug Competition Action Plan, which aims to facilitate more generic competition, promote patient access, and improve the economics of developing generic medicines. 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. The FDA has historically sought to update and enhance the Orange Book to make it more accessible and useful to regulated industry and the public.