federal_register: E8-28657

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E8-28657 Draft Guidance for Industry on the Submission of Patent Information for Certain Old Antibiotics; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Submission of Patent Information for Certain Old Antibiotics." The draft guidance describes the agency's current thinking on the implementation of certain provisions of the Q1 Program Supplemental Funding Act (the Q1 Act) that concern old antibiotics and addresses which sponsors of new drug applications (NDAs) must submit patent information under the Q1 Act by December 5, 2008. 2008-12-03 2008 12 https://www.federalregister.gov/documents/2008/12/03/E8-28657/draft-guidance-for-industry-on-the-submission-of-patent-information-for-certain-old-antibiotics https://www.govinfo.gov/content/pkg/FR-2008-12-03/pdf/E8-28657.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Submission of Patent Information for Certain Old Antibiotics." The draft guidance describes the agency's current thinking on the...

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