OpenRegulations.org » Food and Drug Administration http://www.openregulations.org An alternative interface to the federal government's Regulation.gov service. Thu, 27 Mar 2008 04:00:00 +0000 http://wordpress.org/?v=2.3.3 en Draft Guidance for Industry on Acute Bacterial Otitis Media: Developing Drugs for Treatment; Availability http://www.openregulations.org/2008/01/18/draft-guidance-for-industry-on-acute-bacterial-otitis-media-developing-drugs-for-treatment-availability/ http://www.openregulations.org/2008/01/18/draft-guidance-for-industry-on-acute-bacterial-otitis-media-developing-drugs-for-treatment-availability/#comments Fri, 18 Jan 2008 05:00:00 +0000 Regulations.gov tag:www.regulations.gov://527b4d86f09d176daca2ba1696cf47e3 http://www.openregulations.org/2008/01/18/draft-guidance-for-industry-on-acute-bacterial-otitis-media-developing-drugs-for-treatment-availability/feed/ Human Cells, Tissues, and Cellular and Tissue-Based Products http://www.openregulations.org/2008/01/18/human-cells-tissues-and-cellular-and-tissue-based-products/ http://www.openregulations.org/2008/01/18/human-cells-tissues-and-cellular-and-tissue-based-products/#comments Fri, 18 Jan 2008 05:00:00 +0000 Regulations.gov tag:www.regulations.gov://4b82a49a022774df8c379736e90c6767 http://www.openregulations.org/2008/01/18/human-cells-tissues-and-cellular-and-tissue-based-products/feed/ Anti-Infective Drugs Advisory Committee; Notice of Meeting http://www.openregulations.org/2008/01/17/anti-infective-drugs-advisory-committee-notice-of-meeting/ http://www.openregulations.org/2008/01/17/anti-infective-drugs-advisory-committee-notice-of-meeting/#comments Thu, 17 Jan 2008 05:00:00 +0000 Regulations.gov tag:www.regulations.gov://415cc9e48014395e3f2061fefec4c48e http://www.openregulations.org/2008/01/17/anti-infective-drugs-advisory-committee-notice-of-meeting/feed/ Intramammary Dosage Forms; Cephapirin Sodium http://www.openregulations.org/2008/01/17/intramammary-dosage-forms-cephapirin-sodium/ http://www.openregulations.org/2008/01/17/intramammary-dosage-forms-cephapirin-sodium/#comments Thu, 17 Jan 2008 05:00:00 +0000 Regulations.gov tag:www.regulations.gov://3827ace70fd26cbca6c2f154b66837af http://www.openregulations.org/2008/01/17/intramammary-dosage-forms-cephapirin-sodium/feed/ Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices http://www.openregulations.org/2008/01/16/supplemental-applications-proposing-labeling-changes-for-approved-drugs-biologics-and-medical-devices/ http://www.openregulations.org/2008/01/16/supplemental-applications-proposing-labeling-changes-for-approved-drugs-biologics-and-medical-devices/#comments Wed, 16 Jan 2008 05:00:00 +0000 Regulations.gov tag:www.regulations.gov://607bdc32bd16646718a3ed4baf378d1f http://www.openregulations.org/2008/01/16/supplemental-applications-proposing-labeling-changes-for-approved-drugs-biologics-and-medical-devices/feed/ Animal Cloning Risk Assessment; Risk Management Plan; Guidance for Industry; Availability http://www.openregulations.org/2008/01/16/animal-cloning-risk-assessment-risk-management-plan-guidance-for-industry-availability/ http://www.openregulations.org/2008/01/16/animal-cloning-risk-assessment-risk-management-plan-guidance-for-industry-availability/#comments Wed, 16 Jan 2008 05:00:00 +0000 Regulations.gov tag:www.regulations.gov://711fcde383af0f0386072bd774ab0411 http://www.openregulations.org/2008/01/16/animal-cloning-risk-assessment-risk-management-plan-guidance-for-industry-availability/feed/ Oral Dosage Form New Animal Drugs; Firocoxib Tablets http://www.openregulations.org/2008/01/16/oral-dosage-form-new-animal-drugs-firocoxib-tablets/ http://www.openregulations.org/2008/01/16/oral-dosage-form-new-animal-drugs-firocoxib-tablets/#comments Wed, 16 Jan 2008 05:00:00 +0000 Regulations.gov tag:www.regulations.gov://8098bc3417cc625a5dd37c9639bff760 http://www.openregulations.org/2008/01/16/oral-dosage-form-new-animal-drugs-firocoxib-tablets/feed/ Implantation or Injectable Dosage Form New Animal Drugs; Flunixin http://www.openregulations.org/2008/01/16/implantation-or-injectable-dosage-form-new-animal-drugs-flunixin/ http://www.openregulations.org/2008/01/16/implantation-or-injectable-dosage-form-new-animal-drugs-flunixin/#comments Wed, 16 Jan 2008 05:00:00 +0000 Regulations.gov tag:www.regulations.gov://e4d3e2dbab277d4325566bcc37fee5b4 http://www.openregulations.org/2008/01/16/implantation-or-injectable-dosage-form-new-animal-drugs-flunixin/feed/ Psychopharmacologic Drugs Advisory Committee; Amendment of Notice http://www.openregulations.org/2008/01/16/psychopharmacologic-drugs-advisory-committee-amendment-of-notice/ http://www.openregulations.org/2008/01/16/psychopharmacologic-drugs-advisory-committee-amendment-of-notice/#comments Wed, 16 Jan 2008 05:00:00 +0000 Regulations.gov tag:www.regulations.gov://484caa85c2dbe4b296d3af67d6ce28a6 http://www.openregulations.org/2008/01/16/psychopharmacologic-drugs-advisory-committee-amendment-of-notice/feed/ User Fee Program for Advisory Review of Direct-to-Consumer Television Advertisements for Prescription Drug and Biological Products;Program Will Not Be Implemented http://www.openregulations.org/2008/01/16/user-fee-program-for-advisory-review-of-direct-to-consumer-television-advertisements-for-prescription-drug-and-biological-productsprogram-will-not-be-implemented/ http://www.openregulations.org/2008/01/16/user-fee-program-for-advisory-review-of-direct-to-consumer-television-advertisements-for-prescription-drug-and-biological-productsprogram-will-not-be-implemented/#comments Wed, 16 Jan 2008 05:00:00 +0000 Regulations.gov tag:www.regulations.gov://6d72db84a75f54c466012bf5344ea4e0 http://www.openregulations.org/2008/01/16/user-fee-program-for-advisory-review-of-direct-to-consumer-television-advertisements-for-prescription-drug-and-biological-productsprogram-will-not-be-implemented/feed/ Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions http://www.openregulations.org/2008/01/15/agency-information-collection-activities-announcement-of-office-of-management-and-budget-approval-patent-term-restoration-due-diligence-petitions-filing-format-and-content-of-petitions/ http://www.openregulations.org/2008/01/15/agency-information-collection-activities-announcement-of-office-of-management-and-budget-approval-patent-term-restoration-due-diligence-petitions-filing-format-and-content-of-petitions/#comments Tue, 15 Jan 2008 05:00:00 +0000 Regulations.gov tag:www.regulations.gov://43c935d04e93fa401f1c3e002a180cf4 http://www.openregulations.org/2008/01/15/agency-information-collection-activities-announcement-of-office-of-management-and-budget-approval-patent-term-restoration-due-diligence-petitions-filing-format-and-content-of-petitions/feed/ Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary National Retail Food Regulatory Program Standards http://www.openregulations.org/2008/01/15/agency-information-collection-activities-submission-for-office-of-management-and-budget-review-comment-request-voluntary-national-retail-food-regulatory-program-standards/ http://www.openregulations.org/2008/01/15/agency-information-collection-activities-submission-for-office-of-management-and-budget-review-comment-request-voluntary-national-retail-food-regulatory-program-standards/#comments Tue, 15 Jan 2008 05:00:00 +0000 Regulations.gov tag:www.regulations.gov://c8d779d6a5a4b1b6c5c33210a4ff4e4a http://www.openregulations.org/2008/01/15/agency-information-collection-activities-submission-for-office-of-management-and-budget-review-comment-request-voluntary-national-retail-food-regulatory-program-standards/feed/ Advisory Committees; Tentative Schedule of Meetings for 2008 http://www.openregulations.org/2008/01/15/advisory-committees-tentative-schedule-of-meetings-for-2008/ http://www.openregulations.org/2008/01/15/advisory-committees-tentative-schedule-of-meetings-for-2008/#comments Tue, 15 Jan 2008 05:00:00 +0000 Regulations.gov tag:www.regulations.gov://399a31feb6a38cecb5e22e573680019e http://www.openregulations.org/2008/01/15/advisory-committees-tentative-schedule-of-meetings-for-2008/feed/ Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Form FDA 3671) http://www.openregulations.org/2008/01/15/agency-information-collection-activities-proposed-collection-comment-request-orphan-drugs-common-european-medicines-agencyfood-and-drug-administration-application-form-for-orphan-medicinal-produc/ http://www.openregulations.org/2008/01/15/agency-information-collection-activities-proposed-collection-comment-request-orphan-drugs-common-european-medicines-agencyfood-and-drug-administration-application-form-for-orphan-medicinal-produc/#comments Tue, 15 Jan 2008 05:00:00 +0000 Regulations.gov tag:www.regulations.gov://10f7ba5af42ac3a7fbd5685436c46667 http://www.openregulations.org/2008/01/15/agency-information-collection-activities-proposed-collection-comment-request-orphan-drugs-common-european-medicines-agencyfood-and-drug-administration-application-form-for-orphan-medicinal-produc/feed/ Drug Safety and Risk Management Advisory Committee; Amendment of Notice http://www.openregulations.org/2008/01/15/drug-safety-and-risk-management-advisory-committee-amendment-of-notice/ http://www.openregulations.org/2008/01/15/drug-safety-and-risk-management-advisory-committee-amendment-of-notice/#comments Tue, 15 Jan 2008 05:00:00 +0000 Regulations.gov tag:www.regulations.gov://94fc7fb7f0a30a27698ca270a015ee83 http://www.openregulations.org/2008/01/15/drug-safety-and-risk-management-advisory-committee-amendment-of-notice/feed/ Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Amendments of 2007; Foreign Small Business Qualification Certification, FDA Form 3602A http://www.openregulations.org/2008/01/15/agency-information-collection-activities-proposed-collection-comment-request-medical-device-user-fee-amendments-of-2007-foreign-small-business-qualification-certification-fda-form-3602a/ http://www.openregulations.org/2008/01/15/agency-information-collection-activities-proposed-collection-comment-request-medical-device-user-fee-amendments-of-2007-foreign-small-business-qualification-certification-fda-form-3602a/#comments Tue, 15 Jan 2008 05:00:00 +0000 Regulations.gov tag:www.regulations.gov://5c934323b9f9bc7848762c7cd6facdb9 http://www.openregulations.org/2008/01/15/agency-information-collection-activities-proposed-collection-comment-request-medical-device-user-fee-amendments-of-2007-foreign-small-business-qualification-certification-fda-form-3602a/feed/ Food and Drug Administrations Transition to the Federal Dockets Management System http://www.openregulations.org/2008/01/13/food-and-drug-administrations-transition-to-the-federal-dockets-management-system/ http://www.openregulations.org/2008/01/13/food-and-drug-administrations-transition-to-the-federal-dockets-management-system/#comments Mon, 14 Jan 2008 05:00:00 +0000 Regulations.gov tag:www.regulations.gov://0f560132a0fef2c017cc8b28c4295ac9 http://www.openregulations.org/2008/01/13/food-and-drug-administrations-transition-to-the-federal-dockets-management-system/feed/