What's New 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 requests that health professionals and facilities review and examine all drug/device storage areas to ensure that all recalled heparin products have been removed and are no longer available for patient use. MedWatch Safety Information (5/12/2008)
• The prescribing information for Enbrel (etabercept) is revised to include a boxed warning about infections. (5/1/2008)
• FDA approves Amitiza (lubiprostone) for the treatment of irritable bowel syndrome with constipation in adult women aged 18 and over. (4/29/2008)

Drug Information

• Drugs@FDA Downloadable Data Files
• Drug Approval Reports (updated 4/10/2008)
• Heparin Information
  • FDA requests that health professionals and facilities review and examine all drug/device storage areas to ensure that all recalled heparin products have been removed and are no longer available for patient use. MedWatch Safety Information (5/9/2008)
  • Impurity Evaluation of Heparin Sodium by ¹H-NMR Spectroscopy (updated 4/8/2008)
• National Drug Code Directory Search
• National Drug Code Directory Download
• Novartis will no longer make Zelnorm available under a treatment IND protocol (4/2/2008)
• 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 4/10/2008)
• Warning Letters (updated 2008)

Guidance Documents

• Comprehensive List of Guidance Documents (updated 5/1/2008)
• Guidance Agenda: Guidances CDER is Planning to Develop During Calendar Year 2008 (1/23/2008)
• New/Revised/Withdrawn List for 2008 (5/1/2008)
• New/Revised/Withdrawn List for 2007 (updated 2/1/2008)

CDER Calendar

• Pubic Workshop: Developing Guidance on Conducting Scientifically Sound Pharmacoepidemiologic Safety Studies Using Large Electronic Healthcare Data Sets, Wednesday, May 7, 2008, Silver Spring, MD. Federal Register Notice (5/6/2008)
• FDA/ISPE Co-sponsored Event: Regulatory Perspectives on Hot Topics, Regulatory Trends, and Observations (E07), June 4-5, Washington, DC. Meeting information and registration(5/6/2008)
• FDA/DIA co-sponsored conference: Emerging Regulatory Issues in Genomic Medicine, May 21-23, Mexico City, Mexico. Meeting information and registration (4/21/2008)

 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 4/9/2008)
  • List of Determinations Including Written Request (updated 5/2/2008)
  • Pediatric Exclusivity Granted (updated 4/9/2008)
  • Pediatric Exclusivity Labeling Changes (updated 5/1/2008)
  • Pediatric Exclusivity Statistics (updated 5/9/2008)
  • Spectrum of Diseases/Conditions (updated 4/9/2008)
  • Written Requests Issued (updated 5/9/2008)
• Certification to Accompany Drug, Biological Product, and Device Applications or Submissions (12/26/2007)
• Drug Safety Oversight Board Roster (updated) (5/2/2008)
• Drug Safety Oversight Board Meeting, April 17, 2008, Public Summary (5/13/2008)
• Office of Generic Drugs:
  • First-Time Generics (updated 5/9/2008)
  • Paragraph IV Patent Certifications (updated 5/7/2008)
• Office of Nonprescription Products:
  • Clarification of Recent FDA Initiatives Affecting OTC Drugs
  • Rulemaking History for Nonprescription Products (updated 2/1/2008)
• The Prescription Drug User Fee Act (PDUFA) Dear Colleague Letter, Attachment A   Attachment B

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Last updated: May 13, 2008

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