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 Public Health Advisory Potential Hazards of Skin Products Containing Numbing Ingredients for Relieving Pain from Mammography and Other Medical Tests and Conditions. Information (1/16/2009)
• Follow-up to the March 27, 2008, Communication about the Ongoing Safety Review of Montelukast (Singulair) Information (1/13/2009)
• Follow-up to the January 25, 2008 Early Communication about an Ongoing Data Review for Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor). Information (1/8/2009)
• On Dec. 31, 2008, Celgene issued a Dear Healthcare Professional letter describing a controlled clinical study suggesting that Innohep may increase the risk for death, compared to unfractionated heparin when used to treat elderly patients with renal insufficiency. MedWatch Safety Alert (1/5/2009)
• FDA approves degarelix for injection for patients with advanced prostate cancer. FDA News (12/24/2008)
• ETHEX and FDA notify heathcare professionals of a nationwide recall of a single lot of Hydromorphone HCl 2 mg Tablets due to potential for oversized tablets. MedWatch Safety Information (12/24/2008)
• FDA warns consumers about tainted weight loss pills. FDA News (12/22/2008)

Drug Information

• Drugs@FDA Downloadable Data Files
• Drug Approval Reports (updated 4/10/2008)
• FDA orders companies to stop marketing unapproved drug products that contain papain in a topical dosage form. Questions and Answers (9/22/2008)
• FDA orders companies to stop marketing unapproved ophthalmic balanced salt solutions (BSS). Questions and Answers (9/22/2008)
• 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
• Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS) (9/5/2008)
• Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS): January - March 2008 (9/5/2008)
• Rheumatology Therapeutics (10/15/2008)
• Transition from Chlorofluorocarbon (CFC) Propelled Albuterol Inhalers to Hydrofluroalkane (HFA) Propelled Albuterol Inhalers (podcast) (9/26/2008)

Regulatory Guidance

• Establishment of Prescription Drug User Fee Rates for Fiscal Year 2009 [Text] [PDF] (Posted 7/31/2008)
• Warning Letters

Guidance Documents

• Comprehensive List of Guidance Documents (updated 1/5/2009)
• Guidance Agenda: Guidances CDER is Planning to Develop During Calendar Year 2008 (1/23/2008)
• New/Revised/Withdrawn List for 2008 (1/5/2009)

CDER Calendar

• DIA/FDA/PhRMA Drug Safety Conference: Planning the Lifecycle of Safety Evaluation. October 14, Arlington, VA. Meeting information and registration

Specific Audiences

• Pediatric Drug Development:
  • Best Pharmaceuticals for Children Act of 2007: List of Determinations including Written Request (updated 10/1/2008)
  • BPCA/Pediatric Exclusivity Statistics (updated 1/13/2009)
  • Pediatric Exclusivity Labeling Changes (updated 11/5/2008)
  • Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated 1/14/2009)
• Certification to Accompany Drug, Biological Product, and Device Applications or Submissions (12/26/2007)
• Office of Generic Drugs:
  • First-Time Generics (updated 12/13/2008)
  • List of Authorized Generic Drugs (updated 12/22/2008)
  • Paragraph IV Patent Certifications (updated 1/5/2009)
• Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated 1/9/2009)

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Last updated: January 14, 2009

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