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Briefs, oral arguments, agency decisions and the Federal Register.
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Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices
Federal Register · Rule · Nov 20, 1998
These comments argued that FDA would use this provision to extend the 60-day time period. … Section 554(c)(2) of the act requires a manufacturer to submit periodic progress reports on its clinical studies.
63 FR 64556Health 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 AdministrationFederal Register · Rule · Jan 24, 2000
The comment period for the direct final rule runs concurrently with the comment period of the companion proposed rule. … The comment period runs concurrently with the comment period for the companion proposed rule. Two copies of any comments are to be submitted, except that individuals may submit one copy.
65 FR 3584Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; NULOJIX
Federal Register · Notice · Mar 31, 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 18036Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; XIAFLEX
Federal Register · Notice · Jun 3, 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 31951Health 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 AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; RESTYLANE
Federal Register · Notice · Jun 13, 2006
Submit electronic comments to http://www.fda.gov/dockets/ecomments . … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
71 FR 34138Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; CYPHER
Federal Register · Notice · Feb 3, 2006
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 August 2, 2006.
71 FR 5860Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Uncategorized Document · Jul 22, 1994
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: July 14, 1982.
Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 11, 2000
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … period.
65 FR 7023Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Zemplar
Federal Register · Notice · Mar 1, 1999
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: May 6, 1995.
64 FR 10003Health and Human Services DepartmentFood and Drug AdministrationFederal 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. … period.
63 FR 54719Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; CorlopamRegister
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 28, 1983.
63 FR 54718Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Atacand
Federal Register · Notice · Mar 2, 1999
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: June 15, 1995.
64 FR 10156Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; SingulairRegister
Federal Register · Notice · Mar 3, 1999
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: June 3, 1992.
64 FR 10304Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; SeroquelRegister
Federal Register · Notice · Nov 23, 1998
Under these acts, a product's [[Page 64722]] 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 21, 1988.
63 FR 64721Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; NAROPINSUPTM/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 38565Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; OmnicefRegister Tablets
Federal Register · Notice · May 20, 1999
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: June 1, 1990.
64 FR 27578Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 20, 1999
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: June 1, 1990.
64 FR 27579Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ApligrafSUPTM/SUP
Federal Register · Notice · Apr 30, 1999
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … period.
64 FR 23339Health and Human Services DepartmentFood and Drug Administration
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