Food and Drug Administration

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Draft Guidance for Industry on Acute Bacterial Otitis Media: Developing Drugs for Treatment; Availability

Posted on January 18, 2008

Human Cells, Tissues, and Cellular and Tissue-Based Products

Posted on January 18, 2008

Anti-Infective Drugs Advisory Committee; Notice of Meeting

Posted on January 17, 2008

Intramammary Dosage Forms; Cephapirin Sodium

Posted on January 17, 2008

Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices

Posted on January 16, 2008

Animal Cloning Risk Assessment; Risk Management Plan; Guidance for Industry; Availability

Posted on January 16, 2008

Oral Dosage Form New Animal Drugs; Firocoxib Tablets

Posted on January 16, 2008

Implantation or Injectable Dosage Form New Animal Drugs; Flunixin

Posted on January 16, 2008

Psychopharmacologic Drugs Advisory Committee; Amendment of Notice

Posted on January 16, 2008

User Fee Program for Advisory Review of Direct-to-Consumer Television Advertisements for Prescription Drug and Biological Products;Program Will Not Be Implemented

Posted on January 16, 2008

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions

Posted on January 15, 2008

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary National Retail Food Regulatory Program Standards

Posted on January 15, 2008

Advisory Committees; Tentative Schedule of Meetings for 2008

Posted on January 15, 2008

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)

Posted on January 15, 2008

Drug Safety and Risk Management Advisory Committee; Amendment of Notice

Posted on January 15, 2008

Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Amendments of 2007; Foreign Small Business Qualification Certification, FDA Form 3602A

Posted on January 15, 2008

Food and Drug Administrations Transition to the Federal Dockets Management System

Posted on January 13, 2008

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