Documents
Briefs, oral arguments, agency decisions and the Federal Register.
5,436 results
0.19s
Determination of Regulatory Review Period for Purposes of Patent Extension; COARTEM
Federal Register · Notice · Dec 10, 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 8, 2011.
75 FR 76990Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; INVEGA SUSTENNA
Federal Register · Notice · Jun 24, 2011
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 FD&C Act) (21 U.S.C. 355(i)) became effective: June 2, 2003.
76 FR 37128Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; BESIVANCE
Federal Register · Notice · Dec 6, 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 6, 2011.
75 FR 75679Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; PREVNAR-13
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 18035Health and Human Services DepartmentFood and Drug AdministrationFood Additives Permitted for Direct Addition to Food for Human Consumption
Federal Register · Notice · Nov 16, 1995
Under the Federal Food, Drug, and Cosmetic Act (the act), FDA is required to announce the filing of a food additive petition (21 U.S.C. 348(b)(5)). … Although public notice of a petition is required, the act is silent with respect to public comment on a petition, and thus, the act provides no defined period for such comments.
60 FR 57586Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; SemprexSUPTM-D Capsules
Federal Register · Uncategorized Document · Sep 21, 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 505(i) of the Federal Food, Drug, and Cosmetic Act became effective: September 6, 1984.
Health and Human Services DepartmentFood and Drug AdministrationFood Labeling; Nutrition Labeling, Small Business Exemption
Federal Register · Rule · Aug 7, 1996
This public law extended the time period for compliance with the provisions of section 403(q) of the act until after August 8, 1994, for certain food products. … For products that have been in production for 1 year or more prior to the period for which exemption is claimed, the 12-month period is the period immediately preceding the period for which an exemption
61 FR 40963Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jan 24, 2000
The comment period for this companion proposed rule runs concurrently with the direct final rule comment period. … The comment period for this companion proposed rule runs concurrently with the direct final rule's comment period.
65 FR 3627Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 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 44477Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 8, 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: June 22, 1990.
63 FR 36922Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; NOVOSEVEN
Federal Register · Notice · Jan 24, 2003
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 July 23, 2003.
68 FR 3534Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ZEVALIN
Federal Register · Notice · Apr 21, 2003
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 20, 2003.
68 FR 19547Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; CAMPATH
Federal Register · Notice · Jul 13, 2004
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 January 10, 2005.
69 FR 42059Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; XOLAIR
Federal Register · Notice · Jan 30, 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 July 31, 2006.
71 FR 4920Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; XIGRIS
Federal Register · Notice · Nov 25, 2003
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 24, 2004.
68 FR 66112Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; KINERET
Federal Register · Notice · Sep 28, 2004
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 28, 2005.
69 FR 57938Health and Human Services DepartmentFood and Drug AdministrationPerformance Standards for Ionizing Radiation Emitting Products; Fluoroscopic Equipment; Correction
Federal Register · Rule · Apr 13, 2015
The comment period for this direct final rule runs concurrently with the comment period of the companion proposed rule. … after the comment period ends.
80 FR 19530Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 11, 2007
In enacting the Drug Price Competition and Patent Term Restoration Act of 1984 and the Animal Drug and Patent Term Restoration Act of 1988, Congress sought to encourage development of new, safer, and more … In the Federal Register of July 9, 2007 (72 FR 37242), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received.
72 FR 57950Health and Human Services DepartmentFood and Drug AdministrationSurgeon's and Patient Examination Gloves; Reclassification; Extension of Comment Period
Federal Register · Proposed Rule · Oct 28, 1999
In response to the letters, FDA is extending the comment period for 90 additional days. … Received comments may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday. Dated: October 21, 1999. Margaret M. Dotzel, Acting Associate Commissioner for Policy.
64 FR 58004Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Aug 31, 2016
the last day of the previous comment period. … (Comment 82) One comment noted that at the time of the proposed rule and the comment period, FDA's electronic drug registration and listing system had yet to be developed.
81 FR 60170Health and Human Services DepartmentFood and Drug Administration
Ask Donna what matters in the record.
She can read the source against your case and show you exactly where the answer came from.