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Federal Register · Notice · May 14, 2021
DATES: Electronic or written comments on the application may be submitted beginning May 14, 2021. FDA will establish a closing date for the comment period as described in section I. … FDA believes that this comment period is appropriate given the relatively low volume of information in the MRTPA that has not already been available for public comment as part of the previously authorized
86 FR 26530Health and Human Services DepartmentFood and Drug AdministrationPrivacy Act, Exempt Record System
Federal Register · Rule · Aug 28, 2012
30 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.
77 FR 51910Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 12, 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 33762Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; IMMITICIDERegister
Federal Register · Notice · Mar 18, 1996
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.- A regulatory review period consists of two periods of time: … period.
61 FR 11054Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Refludan®
Federal Register · Notice · Jan 27, 2000
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: January 14, 1995.
65 FR 4431Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ZiagenTM
Federal Register · Notice · Jan 27, 2000
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: July 1, 1994.
65 FR 4431Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; GlucaGen®
Federal Register · Notice · Jan 27, 2000
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 12, 1991.
65 FR 4432Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 27, 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 4433Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Teslascan
Federal Register · Uncategorized Document · Jan 31, 2000
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 5, 1989.
65 FR 4615Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; NuflorRegister
Federal Register · Notice · Nov 26, 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: November 23, 1984.
61 FR 60106Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; AnzemetRegister
Federal Register · Notice · Jan 26, 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: January 5, 1991.
64 FR 3953Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; XelodaSUPTM/SUP
Federal Register · Notice · Jan 27, 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 22, 1994.
64 FR 4115Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; LumenHanceRegister
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. … period.
64 FR 10303Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Trovan
Federal Register · Notice · May 19, 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: August 1, 1992.
64 FR 27272Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; DostinexRegister Tablets
Federal Register · Notice · Aug 4, 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: December 29, 1990.
63 FR 41581Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 7, 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 42408Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension: AniprylRegister
Federal Register · Notice · Aug 4, 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 512(j) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b(j)) became effective: January 15, 1991.
63 FR 41578Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; FarestonRegister
Federal Register · Notice · Aug 11, 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: April 8, 1987.
63 FR 42857Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Requip
Federal Register · Notice · Dec 21, 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: July 14, 1988.
63 FR 70411Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; SkelidRegister
Federal Register · Notice · Oct 9, 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: September 4, 1991.
63 FR 54481Health and Human Services DepartmentFood and Drug Administration
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