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Briefs, oral arguments, agency decisions and the Federal Register.
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Determination of Regulatory Review Period for Purposes of Patent Extension; Silvacote K
Federal Register · Notice · Sep 29, 1998
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.
63 FR 51939Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Sucralose
Federal Register · Notice · Dec 21, 1998
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.
63 FR 70411Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Mar 17, 2014
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.
79 FR 14609Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; VICTRELIS
Federal Register · Notice · Jun 27, 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 36535Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; JUXTAPID
Federal Register · Notice · Apr 6, 2015
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.
80 FR 18414Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; TRADJENTA
Federal Register · Notice · May 13, 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 27316Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; KYPROLIS
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 27877Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Vandetanib
Federal Register · Notice · Jun 11, 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 33563Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; SYNRIBO
Federal Register · Notice · May 7, 2015
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.
80 FR 26271Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; DALIRESP
Federal Register · Notice · Jan 23, 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 3831Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; GADAVIST
Federal Register · Notice · Jan 23, 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 3832Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ZYTIGA
Federal Register · Notice · Feb 28, 2013
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 27, 2013.
78 FR 13684Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; FLECTOR
Federal Register · Notice · Apr 5, 2012
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 October 2, 2012.
77 FR 20644Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; FREESTYLE NAVIGATOR
Federal Register · Notice · Dec 14, 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 June 13, 2011.
75 FR 77878Health and Human Services DepartmentFood and Drug AdministrationIndex of Legally Marketed Unapproved New Animal Drugs for Minor Species
Federal Register · Proposed Rule · Aug 22, 2006
To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. … Comments You may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document.
71 FR 48840Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Feb 23, 2016
ACTION: Proposed rule; reopening of the comment period. … The period for comments regarding information collection issues under the Paperwork Reduction Act of 1995 remains unchanged, where comments were to be submitted until February 22, 2016 (see 81 FR 3751,
81 FR 8869Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; PROGENSA PCA3 ASSAY
Federal Register · Notice · May 30, 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 31119Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; RETEVASE
Federal Register · Notice · Mar 29, 2007
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 September 25, 2007.
72 FR 14818Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; GARDASIL
Federal Register · Notice · May 23, 2007
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 November 19, 2007.
72 FR 28979Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · May 21, 1998
One comment requested that sodium phosphates oral solution products bear a warning against consuming more than 45 mL in a 24-hour period unless directed by a physician. … The agency agrees with the comment that the labeling for sodium phosphates oral solution should include a warning not to ingest more than the recommended dose in a 24-hour period.
63 FR 27836Health and Human Services DepartmentFood and Drug Administration
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