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What's New at CDER by Category
This page lists new and revised documents posted to the CDER web site. Each listing will remain on this page approximately 30 days. The dates listed indicate the dates of posting to the CDER web site, not the dates of origination or revision. When viewing a document, click your browser's "refresh" or "reload" button to make sure you are seeing the latest version.
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In the News
- FDA issues a Public Health Advisory highlighting the correct use of Spiriva (tiotropium bromide inhalation powder) and Foradil (formoterol fumarate inhalation powder) capsules.
- Baxter Healthcare Corporation has voluntarily recalled all of their multi-dose and single-use vials of heparin sodium for injection, and their heparin lock flush solutions. (2/28/2008)
- FDA approves Nexium (esomeprazole magnesium) for use in children ages 1-11 years. (2/28/2008)
Drug Information
- Drugs@FDA Downloadable Data Files
- Drug Approval Reports
- Duragesic (fentanyl transdermal system) Medication Guide
(2/13/2008) - National Drug Code Directory Search
- National Drug Code Directory Download
- Orange Book Search (10/2007)
- Orange Book Current Cumulative Supplement
- Orange Book - Information and Data Files
- Orange Book Monthly Additions and Deletions
Regulatory Guidance
- Cyber Letters (updated 10/5/2007)
- Warning Letters (updated 11/1/2007)
Guidance Documents
- Newly Added Guidance Documents
- Guidance for Industry: Comprehensive List of Guidance Documents
(updated 12/5/2007) - New/Revised/Withdrawn List for 2007 (updated 12/5/2007)
- Guidance Agenda: Guidances CDER is Planning to Develop During Calendar Year 2008 (posted 1/23/2008)
CDER Calendar
- Clinical Trial Design for Community-Acquired Pneumonia; Public Workshop, January 17-18, 2008, Silver Spring, Maryland. Meeting information (12/21/2007)
- PDA/FDA Co-Sponsored Conference Series on Quality Systems, Bethesda, MD, Nov., 1-2, 2007; Dublin, Ireland, Dec. 10-11, 2007; Beijing, China, April 21-22, 2008; Shanghai, China, April 24-25, 2008. Registration and information (5/22/2007)
Specific Audiences
- Best Pharmaceuticals for Children Act of 2007: List of Determinations including Written Request (updated 12/31/2007)
- BPCA/Pediatric Exclusivity Statistics:
- Breakdown of Requested Studies Report (updated 1/16/2008)
- List of Determinations including Written Request (updated 2/15/2008)
- Pediatric Exclusivity Granted (updated 2/15/2008)
- Pediatric Exclusivity Labeling Changes (updated 2/20/2008)
- Pediatric Exclusivity Statistics (updated 2/12/2008)
- Spectrum of Diseases/Conditions (updated 1/16/2008)
- Written Requests Issued (updated 2/12/2008)
- Certification to Accompany Drug, Biological Product, and Device Applications or Submissions (12/26/2007)
- PDUFA Information:
- New addresses and phone numbers for PDUFA correspondence (2/13/2008)
- FDA issues a Federal Register notice to inform companies that the Direct-to-Consumer (DTC) television advertisement user fee program will not commence. Federal Register Notice [HTML] [PDF] (1/16/2008)
- Office of Generic Drugs:
- First-Time Generics (updated 2/11/2008)
- Paragraph IV Patent Certifications (updated 2/21/2008)
- Suitability Petitions (updated 1/14/2008)
- Office of Nonprescription Products:
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