Newly Added Guidance Documents

<!– –> <!– Page Last Updated: 03/31/2011 –> Page Last Updated: 03/31/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Article source: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm121568.htm

Truthful Prescription Drug Advertising and Promotion (Bad Ad Program)

The Prescriber’s Role – Recognize and Report FDA’s educational outreach program is designed to educate healthcare providers about the role they can play in helping the agency make sure that prescription drug advertising and promotion is truthful and not misleading.  The “Bad Ad” Program is administered by the agency’s Division of Drug Marketing, Advertising, and [...]

Drugs@FDA Data Files

<!– –> <!– Page Last Updated: 03/31/2011 –> Page Last Updated: 03/31/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Article source: http://www.fda.gov/Drugs/InformationOnDrugs/ucm079750.htm

LASIK Quality of Life Project

On Oct. 19, 2010, we reported on the progress of the LASIK Quality of Life Collaboration Project (LQOLCP), a government partnership among the FDA, the Department of Defense, and the National Eye Institute. This project examines patient-reported outcomes (PROs) following LASIK. A PRO is any report coming directly from the patient about a health condition and [...]

Summary Information for: Gel-One

Issued March 22, 2011 Approval Order Summary Labeling Other Consumer Information This document is in a Portable Document Format (PDF). Acrobat Reader is required to read this document. Updated March 31, 2011 Article source: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P080020

Consumer Information on: Gel One?

<!– –> <!– Page Last Updated: 03/31/2011 –> Page Last Updated: 03/31/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Article source: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm249209.htm

March 24, 2011 Approval Letter

Our STN: BL 125123/734  Merck Sharp Dohme Corp.Attention: Alison Fisher, Ph.D.P.O. Box 1000UG2D-68North Wales, PA 19454-1099 Dear Dr. Fisher: We have approved your request to supplement your biologics license application (BLA) for Zoster Vaccine Live (ZOSTAVAX®), to include safety and efficacy data to support a label change for the use of ZOSTAVAX in individuals 50 to 59 [...]

Influenza Virus Vaccine for the 2010-2011 Season

<!– –> <!– Page Last Updated: 03/31/2011 –> Page Last Updated: 03/31/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Article source: http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Post-MarketActivities/LotReleases/ucm202750.htm

December 1, 2010 Approval Letter

<!– –> <!– Page Last Updated: 03/31/2011 –> Page Last Updated: 03/31/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Article source: http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm236279.htm

X-Hero and Male Enhancer: Recall

<!– –> <!– Page Last Updated: 03/29/2011 –> Page Last Updated: 03/29/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Article source: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm248814.htm