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 approves pancrelipase (Creon Delayed-Release Capsules) for adult and pediatric patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF), chronic pancreatitis, and other conditions. Drug information (5/1//2009)
• FDA updates the Early Communication about an Ongoing Safety Review of Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) 4/30/2009)
• FDA updates action on Plan B (levonorgestrel) tablets. FDA Statement (4/22/2009)

Drug Information

• Testosterone Gel Safety Concerns Prompt FDA to Require Label Changes, Medication Guide (5/8/2009)
• Risk Evaluation and Mitigation Strategy (REMS) Under Review for CellCept and Myfortic (5/6/2009)
• Drugs@FDA Downloadable Data Files
• Drug Approval Reports (updated 2/18/2009)
• National Drug Code Directory Search
• National Drug Code Directory Download
• Orange Book Search
• Orange Book Current Cumulative Supplement
• Orange Book - Information and Data Files
• Orange Book Monthly Additions and Deletions

Regulatory Guidance

• Warning Letters

Guidance Documents

• Comprehensive List of Guidance Documents (updated 5/7/2009)

• Guidances CDER is Planning to Develop During Calendar Year 2009 (1/23/2008)

• New Revised/Withdrawn List for 2009 (5/7/2009)
  
  
• New/Revised/Withdrawn List for 2008 (1/5/2009)

CDER Calendar

• Public Workshop on Developing a Consolidated Pediatric Rheumatology Observational Registry; May 12-13, 2009
• FDA Small Pharmaceutical Business Assistance Educational Forum Public Workshop, April 23, 2009. Meeting Information and registration
• DIA/FDA/PhRMA Drug Safety Conference: Planning the Lifecycle of Safety Evaluation. October 14, Arlington, VA. Meeting information and registration

Specific Audiences

• Starting June 1 2009, FDA will no longer accept paper submission for Registration and Listing. For more information, visit the FDA Data Standards Council website or contact spl@fda.hhs.gov
• (3/3/2009)
• Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan (Final) (2/13/2009)
• Pediatric Drug Development:
  • Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (5/11/2009)
  • Best Pharmaceuticals for Children Act of 2007: List of Determinations Including Written Request(5/11/2009)
  • BPCA/Pediatric Exclusivity Statistics (5/11/2009)
• Certification to Accompany Drug, Biological Product, and Device Applications or Submissions (12/26/2007)
• Office of Generic Drugs:
  • First-Time Generics (updated 3/24/2009)
  • Generic Drug Petition Tracking: Suitability Tracking Reports (updated 3/24/2009)
  • List of Authorized Generic Drugs (updated 3/27/2009)
  • Paragraph IV Patent Certifications (updated 5/4/2009)
• Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated 5/1/2009)

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Last updated: May 11, 2009

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