Documents
Briefs, oral arguments, agency decisions and the Federal Register.
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Determination of Regulatory Review Period for Purposes of Patent Extension; NormifloRegister
Federal Register · Notice · Oct 13, 1998
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective: October 22, 1987.
63 FR 54717Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; OPTIMMUNERegister
Federal Register · Notice · Apr 5, 1996
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … These periods of time were derived from the following dates: 1. The date an exemption under section 512(j) of the Federal Food, Drug, and Cosmetic Act became effective: May 24, 1990.
61 FR 15264Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ALLEGRASUPTM/SUP
Federal Register · Notice · Jul 11, 1997
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … period.
62 FR 37267Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; GLYSETSUPTM/SUP
Federal Register · Notice · Jul 18, 1997
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … period.
62 FR 38561Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ZYFLOSUPTM/SUP
Federal Register · Notice · Jul 18, 1997
SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
62 FR 38562Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; MENTAX
Federal Register · Notice · Apr 21, 1997
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … period.
62 FR 19324Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 18, 2026
FDA's patent extension activities are conducted under the authority of section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) and the Generic Animal Drug and Patent Term … Restoration Act of 1988 (Pub.
91 FR 7497Health and Human Services DepartmentFood and Drug AdministrationNew Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food
Federal Register · Proposed Rule · Oct 28, 2016
We are reopening the comment period only with respect to the specific issues identified in this supplemental proposed rule. … Reform Act of 1995 (Pub.
81 FR 74962Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; PALLADIA
Federal Register · Notice · May 15, 2014
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document.
79 FR 27879Health and Human Services DepartmentFood and Drug AdministrationRemoval of Designated Journals
Federal Register · Rule · Dec 10, 1999
30 days after the comment period on the direct final rule ends. … FDA is providing a period of 75 days for comment on this direct final rule, to run concurrently with the comment period for the companion proposed rule.
64 FR 69188Health and Human Services DepartmentFood and Drug AdministrationLaboratory Accreditation for Analyses of Foods; Extension of Comment Period
Federal Register · Proposed Rule · Feb 28, 2020
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (PRA) by April 6, 2020 (see the “Paperwork Reduction Act of 1995” section). … We also are extending the comment period for the information collection provisions to make the comment period for the information collection provisions the same as the comment period for the provisions
85 FR 11893Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Medical Device Reporting; Baseline Reports
Federal Register · Rule · Jun 13, 2008
days after the comment period on this direct final rule ends. … The comment period for this direct final rule runs concurrently with the comment period of the companion proposed rule.
73 FR 33692Health and Human Services DepartmentFood and Drug AdministrationQuality Mammography Standards; Companion Document to Direct Final Rule
Federal Register · Proposed Rule · Jun 17, 1999
final rule in the Federal Register within 30 days after the comment period on the direct final rule ends. … The comment period for this companion proposed rule runs concurrently with the direct final rule's comment period.
64 FR 32443Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; INVEGA
Federal Register · Notice · May 14, 2008
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective : February 14, 2003.
73 FR 27837Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; TYZEKA
Federal Register · Notice · May 15, 2008
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective : July 1, 2000.
73 FR 28119Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; SOMATULINE DEPOT
Federal Register · Notice · Nov 17, 2008
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by May 18, 2009.
73 FR 67874Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; IXEMPRA
Federal Register · Notice · Nov 10, 2008
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective : July 30, 1999.
73 FR 66646Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; TYKERB
Federal Register · Notice · Nov 10, 2008
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by May 11, 2009.
73 FR 66647Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ERAXIS
Federal Register · Notice · Jun 23, 2008
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective : August 14, 1996.
73 FR 35402Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; EYLEA
Federal Register · Notice · Apr 2, 2014
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document.
79 FR 18566Health and Human Services DepartmentFood and Drug Administration
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