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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; 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 AdministrationMedical Devices; Humanitarian Use Devices
Federal Register · Rule · Jun 26, 1996
Although these time periods are longer than the 30 day IDE review period suggested by the comment, FDA believes that they are warranted. … Although the December 21, 1992, proposed rule provided a 60-day comment period under the Paperwork Reduction Act of 1980, and this final rule is based on the comments received, as required by 44 U.S.C.
61 FR 33232Health 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 AdministrationFederal Register · Notice · Mar 19, 2020
ACTION: Notice of availability; reopening of the comment period. … FDA is reopening the comment period until May 18, 2020.
85 FR 15788Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 26, 2015
ACTION: Notice of draft guidance availability and public meeting; request for comments; extension of comment period. … Food, Drug, and Cosmetic Act.
80 FR 51822Health 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 AdministrationExports: Notification and Recordkeeping Requirements; Extension of Comment Period
Federal Register · Proposed Rule · Jun 17, 1999
, the comment period for the proposed rule that appeared in the Federal Register of April 2, 1999 (64 FR 15944). … Therefore, FDA is extending the comment period until July 16, 1999.
64 FR 32442Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Dec 19, 2011
Submit comments on the information collection requirements under the Paperwork Reduction Act of 1995 by January 3, 2012 (see the “Paperwork Reduction Act of 1995” section of this document). … Act of 1995 (Pub.
76 FR 78530Health 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 AdministrationFederal Register · Proposed Rule · Nov 30, 2015
ACTION: Notice of proposed rulemaking; reopening of the comment period. … regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
80 FR 74737Health and Human Services DepartmentFood and Drug AdministrationUnapproved Animal Drugs; Extension of Comment Period
Federal Register · Notice · Feb 18, 2011
FDA-2010-N-0528] Unapproved Animal Drugs; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Request for comments; extension of comment period. … The Agency has received requests for a 60-day extension of the comment period.
76 FR 9584Health and Human Services DepartmentFood and Drug Administration
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