FDA CDER News

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).

Consumer Directed Questions and Answers about FDA’s Initiative Against Contaminated Weight Loss Product

Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 3 Test for Particulate Contamination: Subvisible Particles General Chapter

Investigational Human Drugs: Clinical Investigator Inspection List (updated)

Division of Drug Marketing, Advertising, and Communications - Research (updated)

Comprehensive List of Guidance Documents

New/Revised/Withdrawn List for 2008

Labeling OTC Human Drug Products -- Questions and Answers

Designating Additions to the Current List of Tropical Diseases in the Food and Drug Administration Amendments Act; Public Hearing, 12/12/2008; Presentations

Drug Firm Annual Registration Status updated. The status report now includes Data Universal Numbering System Number.