FDA Press Releases

2005

Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec

December 2005

• FDA Issues Consumer Alert on Contaminated Pet Food (Dec. 30)
• FDA Approves New Treatment for Myelodysplastic Syndrome (MDS) (Dec. 28)
• FDA Issues Recall of Tropical Fruit Ackee Because of Possible Health Risks (Dec. 23)
• FDA Allows Barley Products to Claim Reduction in Risk of Coronary Heart Disease (Dec. 23)
• FDA to Strengthen Research and Communication with AHRQ (Dec. 23)
• FDA Approves Tamiflu for Prevention of Influenza in Children Under Age 12 (Dec. 22)
• FDA Proposes New Guidance to Further Reduce Children's Risk From Lead Exposure in Certain Candy (Dec. 22)
• FDA Tentatively Approves a Generic AIDS Drug in Association with the President's Emergency Plan for AIDS Relief (Dec. 21)
• FDA Approves New Treatment for Advanced Kidney Cancer (Dec. 20)
• FDA to Require Food Manufacturers to List Food Allergens (Dec. 20)
• FDA Joins Children's Health Groups to Mark Historic Milestone for Pediatric Drugs; 100 Drug Labels Have New Pediatric Information Since 1997 (Dec. 19)
• FDA Issues Public Health Advisory on use of NeutroSpec, [Technetium (99m TC) Fanolesomab], Imaging Agent for Diagnosis of Appendicitis (Dec. 19)
• FDA Warns Consumers to Avoid Drinking Raw Milk (Dec. 16)
• FDA Operation Reveals Many Drugs Promoted as "Canadian" Products Really Originate From Other Countries (Dec. 16)
• FDA Announces Partnership with Critical Path Institute to Conduct Essential Research to Spur Medical Innovation (Dec. 16)
• FDA Notifies Health Care Professionals of Problem with Baxter Healthcare's Meridian Hemodialysis Instrument (Dec.16)
• FDA Acts to Protect Public from Fraudulent Avian Flu Therapies (Dec. 13)
• Statement by Acting FDA Commissioner Dr. Andrew von Eschenbach on the Opening of the Japanese Market to U.S. Beef (Dec. 12)
• Gulf States, Feds Report on Seafood (Dec. 9)
• FDA Advising of Risk of Birth Defects with Paxil (Dec. 8)
• FDA Seeks Input on Communication of Drug Safety Information (Dec. 7)
• FDA Warns Consumers About Unapproved and Bacterially-Contaminated Miracle II Neutralizer and Miracle II Neutralizer Gel Drug Products (Dec. 6)
• FDA Acts to Seize Ephedra-Containing Dietary Supplements (Dec. 6)
• FDA Approves First Test to Screen for West Nile Virus in Donors of Blood, Organs, Cells and Tissues (Dec. 1)

November 2005

• Manufacturer of Over-the-Counter (OTC) Eye Drops Signs Consent Decree with FDA (Nov. 29)
• FDA Names New Director for Office of Women's Health:Kathleen Uhl, MD, FAAFP (Nov. 21)
• PDUFA White Paper Available (Nov. 11)
• FDA Updates Labeling for Ortho Evra Contraceptive Patch (Nov. 10)
• FDA's Dr. Jesse Goodman Honored by Institute of Medicine (Nov. 10)
• FDA Issues Warning Letters to Marketers of Unapproved "Alternative Hormone Therapies" (Nov. 10)
• FDA Seeks Public Input on Renewal Process for Prescription Drug User Fee Act (PDUFA) (Nov. 10)
• FDA Approves First Oral Drug for Chronic Iron Overload (Nov. 9)
• FDA and EU (European Commission and EMEA) Extend Confidentiality Arrangements for Five More Years (Nov. 8)
• FDA Tentatively Approves a Generic AIDS Drug in Association with the President’s Emergency Plan for AIDS Relief (Nov. 4)
• USDA and HHS Agencies Work Together to Examine the Jurisdiction of Certain Food Categories; Agencies to Hold Public Meeting (Nov. 3)
• Dr. Janet Woodcock Honored for Scientific Leadership (Nov. 3)
• FDA and Industry to Collaborate on Better Ways to Predict Liver Toxicity in Human Drug Trials - Part of FDA's Critical Path Initiative to Modernizing Drug Development (Nov. 2)
• FDA Announces the Use of New Electronic Drug Labels to Help Better Inform the Public and Improve Patient Safety (Nov. 2)

October 2005

• FDA Approves Arranon for Rare Leukemia and Lymphoma (Oct. 31)
• FDA Provides Important Safety Information on Blood Glucose Meters (Oct. 26)
• FDA Provides Information on Investigation into Human Tissue for Transplantation (Oct. 26)
• FDA Announces Rapid Response Team to Combat Pandemic (Avian) Flu (Oct. 24)
• Mexico, United States, Canada Combat Weight Loss Fraud (Oct. 24)
• FDA Warns Companies To Stop Marketing Fruit Products With Unproven Disease Treatment and Prevention Claims (Oct. 24)
• FDA Names New Director of Drug Safety; Goals for Center for Drugs Reorganization Announced (Oct. 19)
• Recognition Ceremony for New Shuttle Service for FDA Employees (Oct. 17)
• FDA Update on Influenza Vaccine Supply (Oct. 17)
• United States Marshals Seize Violative Infusion Pumps Made by Baxter Healthcare Corporation (Oct. 14)
• FDA Hosts International Forum on U.S. Drug Regulation (Oct. 7)
• FDA Proposes Additional ''Mad Cow'' Safeguards (Oct. 4)
• FDA Issues Nationwide Health Alert on Dole Pre-Packaged Salads (Oct. 2)

September 2005

• FDA and CDC Issue Alert on Menactra Meningococcal Vaccine and Guillain Barre Syndrome (Sept. 30)
• FDA Issues Public Health Advisory on Strattera (Atomoxetine) for Attention Deficit Disorder (Sept. 29)
• DHHS and DHS Issue Bioterrorism Act Food Facilities Registration Final Rule (Sept. 28)
• 2005 Food Code Updates Food Safety Guidelines (Sept. 26)
• Dr. Throckmorton Appointed Deputy Director of FDA’s Center for Drugs (Sept. 22)
• FDA Statement on Approvable Letter to Inamed Corporation (Sept. 21,
• FDA Approves First Pediatric Generic AIDS Drug for U.S. Marketing (Sept. 19)
• Theresa A. Toigo is Appointed Acting Director of FDA's Office of Women's Health (Sept. 16, 2005)
• FDA Releases Results of Study on Defibrillator and Pacemaker Malfunctions Part of Agency Drive to Improve Device Safety Monitoring and Public Communications (Sept. 16)
• FDA Tentatively Approves Generic Zidovudine Oral Solution, for HIV/AIDS Treatment in Association with the President’s Emergency Plan for AIDS Relief (Sept. 8)
• FDA Amends Interim Final Rule "Use of Materials Derived from Cattle in Human Food and Cosmetics" (Sept. 6)

August 2005

• Federal Authorities Cease Sale and Distribution of Counterfeit Lipitor (Aug. 31)
• FDA Approves New Influenza Vaccine for Upcoming Flu Season (Aug. 31)
• FDA Statement on Chiron Corporation Inspection (Aug. 31)
• FDA, USDA Report Results of BSE Investigation (Aug. 30)
• FDA Announces Nationwide Recall of Medline Brand of Alcohol-Free Mouthwash and Hygiene Kits Containing Mouthwash Because of Possible Health Risk (Aug. 29)
• FDA Offers Valuable Food Safety Information for Hurricane Katrina Aftermath (Aug. 29)
• FDA Takes Action on Plan B: Statement by FDA Commissioner Lester M. Crawford (Aug. 26)
• Linda R. Tollefson is Appointed as FDA's New Assistant Commissioner for Science (Aug. 23)
• FDA Clears Genetic Test That Advances Personalized Medicine Test Helps Determine Safety of Drug Therapy (Aug. 22)
• Collaboration Called Key to Overcoming Obstacles to Drug Development (AAMC, Aug. 15)
• FDA Notifies Consumers of Recall of Esh Foods Cream Cheese Spreads Due to Undeclared Allergens (Aug. 12)
• FDA Announces Strengthened Risk Management Program to Enhance Safe Use of Isotretinoin (Accutane) for Treating Severe Acne (Aug. 12)
• FDA Posts Drug Safety Oversight Board Meeting Summary (Aug. 5)

July 2005

• FDA Alerts U.S. Residents to Recall of Counterfeit "Lipitor" Sold in the United Kingdom (July 29)
• FDA Commissioner Announces Important Personnel Changes (July 29)
• FDA's Center for Drug Evaluation and Research Gets Permanent Leadership (July 29)
• FDA Statement on Approvable Letter to Mentor Corporation (July 28)
• FDA Announces Final Decision About Veterinary Medicine (July 28)
• FDA-Recommended Seizure Carried Out by United States Marshals Under Court Order (July 28)
• FDA Blocks Sale of Illegal Drugs U.S. District Judge Issues Injunction Against Florida Company (July 27)
• FDA Joins Other Feds, States, Private Industry to Protect Against Agroterrorism (July 26)
• FDA Announces Guidant's Class I Pacemaker Recall (July 22)
• FDA Announces Class I Recall of Baxter Healthcare's Colleague Volumetric Infusion Pumps (July 21)
• FDA Issues Safety Alert on SMOKED SALMON, SKINLESS SLICED SIDES Due to Possible Health Risk (July 20)
• FDA Issues Public Health Advisory for Mifepristone (July 19)
• FDA Issues Public Health Advisory on the Fentanyl Patch (July 15)
• FDA Asks Purdue Pharma to Withdraw Palladone for Safety Reasons (July 13)
• HHS/FDA Tentatively Approves Another First-Time Generic AIDS Drug Associated with the President's Emergency Plan for AIDS Relief (July 13)
• FDA Issues Nationwide Health Alert on Orchid Island Unpasteurized Orange Juice Products (July 8)
• HHS/FDA Tentatively Approves Another First-Time Generic AIDS Drug Associated with the President's Emergency Plan for AIDS Relief (July 8)
• FDA Updates Labeling for Viagra, Cialis and Levitra for Rare Post-Marketing Reports of Eye Problems (July 8)
• FDA Issues Nationwide Alert on Possible Health Risk Associated with Cold Stone Creamery "Cake Batter" Ice Cream (July 1)
• FDA Tentatively Approves Another First Time Generic AIDS Drug Associated with the President's Emergency Plan for AIDS Relief (July 1)
• FDA Updates Consumers on Guidant Corporation's Implantable Defibrillators (July 1)

June 2005

• FDA Issues Information for Consumers about Claims for Green Tea and Certain Cancers (June 30)
• Revised: FDA Notifies Public that Vail Products, Inc., Issues Nationwide Recall
  of Enclosed Bed Systems (June 30)
• New Leadership for Safer Drugs (June 28)
• FDA Notifies Public That Vail Products, Inc. Issues Nationwide Recall of Enclosed Bed Systems (June 24)
• Acting Commissioner Crawford, Singapore's Tan Sign Medical Products Group MOU (June 24)
• FDA Statement on USDA BSE Positive Test Results (June 24)
• FDA Statement on Guidant Corporation's Worldwide Physician Communications (June 24)
• FDA Tentatively Approves Generic Efavirenz – Product Eligible To Be Considered Under the President's Emergency Plan for AIDS Relief (June 24)
• FDA Approves BiDil Heart Failure Drug for Black Patients (June 23)
• FDA Approves New Therapy for HIV Patients with Advanced Disease (June 23)
• Statement from FDA on the Safety of Animal Cloning in the Food Supply (June 22)
• FDA Tentatively Approves First Generic Nevirapine under the President’s Emergency Plan for AIDS Relief (June 20)
• Statement on First Meeting of FDA's Drug Safety Oversight Board (June 17)
• FDA Issues Nationwide Notification of Recall of Certain Guidant Implantable Defibrillators and Cardiac Resynchronization Therapy Defibrillators (June 17)
• FDA Tentatively Approves a Generic AIDS Drug under the President's Emergency Plan for AIDS Relief (June 15)
• FDA Works to Trace Source of Foodborne Illness in Florida (June 3)

May 2005

• FDA Advises Consumers about Recalled Drugs from Able Laboratories (May 27)
• FDA Consumer Named Best National Magazine in 2004 NAGC Blue Pencil Competition (May 20)
• FDA Sets Up RSS Feed (May 18)
• FDA Continues Combating Counterfeit Drugs Annual Update Reports on Progress (May 18)
• USDA and HHS Propose to Modernize Principles for Food Standards of Identity (May 17)
• FDA Approves First DNA-based Test to Detect Cystic Fibrosis (May 9)

April 2005

• Margaret O'K. Glavin Succeeds John M. Taylor III as Associate Commissioner for Regulatory Affairs (April 29)
• GlaxoSmithKline Signs Consent Decree with FDA; Agrees to Correct Manufacturing Deficiencies (April 28)
• FDA Names Dr. Richard Pazdur to Lead New Cancer Office (April 22)
• FDA Approves New Oral Rinse to Help Treat Gingivitis (April 18)
• FDA Issues Nationwide Alert on SeaSpecialties Brand "Mama's Smoked Nova Salmon" in 8 Ounce Vacuum Packed Bags Because of Possible Health Risk (April 8)
• FDA Approves Sealant to Prevent Cerebrospinal Fluid Leaks After Brain Surgery (April 7)
• FDA Announces Series of Changes to the Class of Marketed Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (April 7)
• FDA Asking for Public Comment on Food Label Changes (April 1)

March 2005

• FDA Issues Final Risk Minimization Guidances (March 24)
• FDA Approves First-of-Kind Device to Treat Descending Thoracic Aneurysms (March 23)
• FDA Works to Speed the Advent of New, More Effective Personalized Medicines (March 22)
• FDA Issues Nationwide Alert on ONE lot of Pharmedium Services magnesium sulfate solution (March 18)
• FDA Issues Health Advisory About Certain Soft Cheese Made From Raw Milk (March 14)
• FDA-Recommended Seizure Carried out by United States Marshals Under Court Order (March 14)
• FDA Web Site Receives 'Silver' Award in Health Information Competition (March 11)
• Dr. Randall Lutter to Succeed Retiring William Hubbard as FDA Associate Commissioner for Policy and Planning (March 4)
• U.S. Marshals Seize Lots of GlaxoSmithKline's Paxil CR and Avandamet Tablets Because of Continuing Good Manufacturing Practice Violations (March 4)
• FDA Assesses New Report on Acrylamide (March 3)
• Statement from Dr. Jesse Goodman, Director, Center for Biologics Evaluation and Research (CBER), Regarding the MHRA Action Today (March 2)
• FDA Provides Updated Patient and Healthcare Provider Information Concerning Crestor (March 2)

February 2005

• FDA Issues Public Health Advisory on Tysabri, a New Drug for MS (Feb. 25, 2005)
• FDA Improvements in Drug Safety Monitoring (FDA Fact Sheet, Feb. 15)
• FDA Proposes Draft Guidance on Medical Products to Treat Radiation Contamination (Feb 14)
• Statement on Adderall (Feb. 9)
• FDA Proposes $1.9 Billion Budget to Expand Food Defense Effort, Increase Drug Safety and Medical Device Review (Feb. 7)
• FDA Renews Nationwide Alert on IV Flush Brand of Heparin or Sodium Chloride Intravenous Catheter Flushes in Light of New Contamination Reports (Feb. 4)

January 2005

• FDA Issues Nationwide Alert on IV Flush Brand of Preloaded Syringes Containing Heparin or Sodium Chloride Intravenous Catheter Flushes (Jan. 31)
• FDA Grants Tentative Approval to Generic AIDS Drug Regimen for Potential Purchase Under the President's Emergency Plan for AIDS Relief (Jan. 25)
• FDA Announces Dates for Public Meeting on Non-Steroidal Anti-Inflammatory Drugs (Jan. 14)
• Kathy Heuer Appointed Chief Financial Officer and Associate Commissioner for Management (Jan. 12)