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 informs healthcare professionals that serious and sometimes fatal hypersensitivity reactions (HSR) caused by abacavir therapy are significantly more common in patients with a particular human leukocyte antigen (HLA) allele, HLA-B*5701. MedWatch Safety Information (7/24/2008)
• FDA updates healthcare professionals about recent changes made to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information for micro-bubble contrast agents. Drug Information (7/17/2008)
• Roxane Laboratories informs healthcare professionals of the recall of two lots of Sodium Polystyrene Sulfonate Suspension, a product used to treat hyperkalemia. MedWatch Safety Information (7/17/2008)

Drug Information

• Drugs@FDA Downloadable Data Files
• Drug Approval Reports (updated 4/10/2008)
• Heparin Information
  • Heparin Screening Methods (updated 7/7/2008)
  • FDA updates information on adverse event reports and heparin (6/16/2008)
  • Questions and Answers on Heparin Sodium Injection (Baxter) (updated 6/18/2008)
• 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
• Public Health Emergency Home Preparation Instructions for Doxycycline (7/2/2008)
• Statistical Review and Evaluation: Antiepileptic Drugs and Suicidality

Regulatory Guidance

• Cyber Letters (updated 4/10/2008)
• Warning Letters (updated 2008)

Guidance Documents

• Comprehensive List of Guidance Documents (updated 7/1/2008)
• Guidance Agenda: Guidances CDER is Planning to Develop During Calendar Year 2008 (1/23/2008)
• New/Revised/Withdrawn List for 2008 (7/1/2008)
• New/Revised/Withdrawn List for 2007 (updated 2/1/2008)

CDER Calendar

• FDA/Consumer Healthcare Products Association Workshop: Current Good Manufacturing Practices (CGMP) 2008. August 4, 2008, Chicago, Illinois. Meeting information and registration (6/24/2008)

 Specific Audiences

• Pediatric Drug Development:
  • Best Pharmaceuticals for Children Act of 2007: List of Determinations including Written Request (updated 7/24/2008)
  • BPCA/Pediatric Exclusivity Statistics (updated 7/11/2008)
  • Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated 7/25/2008)
• 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 7/22/2008)
  • Paragraph IV Patent Certifications (updated 7/22/2008)
• Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated 6/20/2008)
• The Prescription Drug User Fee Act (PDUFA) Dear Colleague Letter, Attachment A   Attachment B

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Last updated: July 25, 2008

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