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Determination of Regulatory Review Period for Purposes of Patent Extension; RANEXA
Federal Register · Notice · Apr 2, 2007
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 18, 1987.
72 FR 15700Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 26, 2006
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 : March 29, 1998.
71 FR 56157Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 29, 2006
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 : January 10, 1996.
71 FR 57545Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; BYETTA
Federal Register · Notice · Oct 2, 2006
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 10, 1999.
71 FR 57977Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; NATRECOR
Federal Register · Notice · Oct 2, 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 April 2, 2007.
71 FR 57979Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; INSPRA
Federal Register · Notice · Jun 16, 2006
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) became effective: November 24, 1996.
71 FR 34944Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; FOSRENOL
Federal Register · Notice · May 22, 2007
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 13, 1998.
72 FR 28700Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; CETROTIDE
Federal Register · Notice · Jun 9, 2006
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 : November 10, 1994.
71 FR 33465Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; DUTASTERIDE
Federal Register · Notice · Jun 14, 2006
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 : May 25, 1995.
71 FR 34374Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; CUBICIN
Federal Register · Notice · Jun 14, 2006
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 : January 22, 1986.
71 FR 34375Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; MYCAMINE
Federal Register · Notice · Mar 23, 2006
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 : March 29, 1998.
71 FR 14709Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; RELPAX
Federal Register · Notice · Mar 15, 2006
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 : March 31, 1995.
71 FR 13408Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; BENICAR
Federal Register · Notice · Jul 31, 2003
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 : June 1, 1995.
68 FR 44954Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Definity
Federal Register · Notice · Jul 26, 2002
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.
67 FR 48919Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; TEQUIN
Federal Register · Notice · Mar 26, 2003
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 27, 1996.
68 FR 14665Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jan 26, 2018
30 days after the comment period ends. … The comment period for this companion proposed rule runs concurrently with the comment period for the direct final rule.
83 FR 3631Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; GenESARegister
Federal Register · Notice · May 11, 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, 1990.
64 FR 25350Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Reporting; Certification and U.S. Designated Agents
Federal Register · Proposed Rule · Jul 23, 1996
The certification period will be the 12-month period ending 1 month before the certification date. … This certification period will be the 12-month period ending 1 month before the certification date.
61 FR 38348Health and Human Services DepartmentFood and Drug AdministrationFood Labeling; Timeframe for Final Rules Authorizing Use of Health Claims
Federal Register · Rule · May 22, 1997
If a proposal for a health claim were ever received by the public without controversy, FDA would act rapidly to issue a final rule shortly after the comment period closed. … Consequently, the agency has modified proposed Sec. 101.70(j)(4)(ii) to provide that FDA may extend the comment period for a period of no more than 90 days.
62 FR 28230Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; EFFIENT
Federal Register · Notice · Sep 7, 2010
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 March 7, 2011.
75 FR 54344Health and Human Services DepartmentFood and Drug Administration
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