FDA News Release Archives
Press Releases

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2004

November 2004

• FDA Acts to Strengthen the Safety Program for Marketed Drugs (November 5)
• FDA Announces Major Initiatives for Dietary Supplements (November 4)
• FDA Allows Qualified Health Claim to Decrease Risk of Coronary Heart Disease (November 1)

October 2004

• FDA Issues Nationwide Alert "Jelly Candy Pops Sour Zip Kids" Brand Halloween Candy May Contain Undeclared Food Allergen (October 29)
• FDA Warns Consumers of the Dangers of Using Decorative Contact Lenses Without Proper Professional Involvement (October 28)
• FDA Names Dr. Edward Otto as New Director of the Office of Cellular, Tissue and Gene Therapies (October 28)
• FDA Team Completes Inspection of Chiron's Liverpool Flu Vaccine Plant (October 15)
• FDA Launches a Multi-Pronged Strategy to Strengthen Safeguards for Children Treated With Antidepressant Medications (October 15)
• FDA and U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) Working Cooperatively to Address Flu Vaccine Quality at Chiron's U.K. Facility (October 13)

September 2004

• FDA Issues Public Health Advisory on Vioxx as its Manufacturer Voluntarily Withdraws the Product (September 30)
• September is National Menopause Awareness Month! (September 29)
• FDA Issues Final Report on Its “21st Century” Initiative on the Regulation of Pharmaceutical Manufacturing (September 29)
• Advanced Bionics Conducts Voluntary Recall of Cochlear Implants (September 24)
• USDA, FDA And DHS Sign Agreement With NASDA to Make Nation's Agriculture and Food Supply More Secure (FDA/USDA release, September 23)
• FDA and the National Alliance for Hispanic Health Reaffirm Their Commitment To Support Healthy and Informed Families (September 22)
• FDA Proposes Further Action to Improve Farm-to-Table Shell Egg Safety (September 20)
• FDA Statement on Recommendations of the Psychopharmacologic Drugs and Pediatric Advisory Committees (September 16)
• FDA Announces Qualified Health Claims for Omega-3 Fatty Acids (September 8)
• Sheila Dearybury Walcoff Appointed Associate FDA Commissioner for External Relations (September 7, 2004)
• FDA Approves Drug for Neuropathic Pain Associated With Diabetes (September 7)
• Guilty Pleas Entered on FDA Case Involving Illegal Drug Trafficking (September 2)

August 2004

• Stent Approved to Help Prevent Stroke (August 31)
• FDA Approves Drug to Treat Skin Infections in Dogs (August 30)
• FDA Gets Significant Guilty Pleas (August 27)
• Nellcor Puritan Bennet CO2 Probes Recalled Due to Contamination (August 26)
• Statement on Vermont's Lawsuit on Importing Prescription Drugs from Canada (August 20)
• Leslye M. Fraser, S.M., J.D., Named Director of FDA’s Office of Regulations and Policy, Center for Food Safety and Applied Nutrition (August 20)
• Rx Depot Agrees in Consent Decree to Cease Importing Unapproved Drugs from Canada (August 20)
• FDA Offers Information for Hurricane Aftermath (August 13)
• FDA Approves Drugs to Treat Internal Contamination from Radioactive Elements (August 11)
• FDA Seeks Injunction Against Utah Medical Device Manufacturer (August 10)
• FDA Alerts Consumers That Certain Healthy Way Brand Sprouted Grain Bread Products May Contain Stone Pieces (August 9)
• FDA Approves Sculptra for HIV Patients (August 3)
• FDA Approves Two Fixed-Dose Combination Drug Products for the Treatment of HIV-1 Infection (August 2)
• Acting FDA Commissioner Outlines Priorities for Next Six Months (August 2)

July 2004

• FDA Analyses Finds Ground Castor Beans - Not Purified Ricin -- in Two Tampered Baby Food Jars In Irvine, California Case (July 28, 2004)
• FDA Issues Alert on Foodborne Illness Outbreaks in Pennsylvania and Mid-Atlantic States (July 23, 2004)
• Metabolife, Founder Indicted for Lying to FDA about Ephedra Risks (DOJ, July 22)
• FDA Announces Standard Format That Drug Sponsors Can Use to Submit Human Drug Clinical Trial Data (July 21)
• FDA Commends Passage by the House of Representatives of S. 741, a Bill Providing Improved Consumer Protection and Incentives for Animal Drug Development (July 20)
• Schultz Named Director of FDA's Devices Center (July 20)
• FDA Proposes Changes To Provide Clearer Information To Drug Sponsors Concerning Reviews of Their New Drug Applications (July 19)
• FDA to Establish New Cancer Office and Program (July 16)
• FDA Issues Alert on Foodborne Illness Outbreaks in Pennsylvania And Mid-Atlantic States (July 16)
• Acting FDA Commissioner Dr. Lester M. Crawford Names Michael M. Landa, Esq., Deputy Director of FDA's Center for Food Safety and Applied Nutrition (July 15)
• FDA Approves New Use of Drug to Treat Superficial Basal Cell Carcinoma, a Type of Skin Cancer (July 15)
• FDA Test Results of Prescription Drugs from Bogus Canadian Website Show All Products Are Fake and Substandard (July 13)
• U.S. District Judge Issues Permanent Injunction Against Lane Labs-USA, Inc. and Orders Firm to Refund Money to Purchasers of Illegally Marketed Unapproved Drugs (July 13)
• Statement by Dr. Lester M. Crawford, Acting FDA Commissioner in Response to A Release Issued Today by Rep. Maurice Hinchey (July 13)
• USDA and HHS Strengthen Safeguards against Bovine Spongiform Encephalopathy (July 9, 2004)

June 2004

• FDA is Alerting the Public to Counterfeit Viagra Found in Two California Pharmacies (June 30)
• FDA Issues Nationwide Alert on Bucks County Distributors Food Products That May Contain Undeclared Food Allergens (June 25)
• Statement on FDA Test Results from Washington State Dairy Cattle (June 23)
• Lengthy Jail Sentence for Vendor of Laetrile—A Quack Medication to Treat Cancer Patients (June 22)
• Statement on Dairy Cattle Deaths in Washington State (June 21)
• Dr. Laura Tarantino Named Director of FDA's Office of Food Additive Safety, Center for Food Safety and Applied Nutrition (June 16)
• FDA Review of "Outside Activity" Requests Identifies No Additional Approved Outside Activities of Concern (June 4)
• Brochure Urges Consumers to Take More Active Role in Health Care (CFH, June 4)
• Sprouters Northwest, Inc. Recalls Raw Alfalfa Sprouts Due to Possible Health Risk (June 3)
• FDA Investigating Illnesses Associated With School Lunches Served in Massachusetts (June 2)

May 2004

• FDA Finalizes Rule on Administrative Detention of Suspect Food (May 27)
• FDA Issues Alert on Additional Recalled Stocks of Paramount Farms
  Raw Almonds (May 21)
• FDA Issues Alert on Foodborne Illness Associated with Certain Basil and Mesculin/Spring Mix Salad Products (May 21)
• FDA Finalizes New Rule on Donor Eligibility for Human Tissues and Cells (May 20)
• FDA Approves New Drug for Bone Marrow Disease (May 19)
• FDA Approves New Indication for Taxotere -- Prostate Cancer (May 19)
• Statement by Dr. Lester M. Crawford, Acting FDA Commissioner, on Outside Activities of FDA Employees (May 18)
• FDA Announces Recall of "DU" Brand Nasal Decongestant Due To Possible Health Risk (May 14)
• FDA to Determine Health Significance of Low Furan Levels in Foods (May 7)
• FDA Issues Not Approvable Letter to Barr Labs; Outlines Pathway for Future Approval (May 7)
• British Man Charged in Extortion Plot Involving Tainted Food Products (DoJ, May 7)
• FDA Announces Modernization of Food Good Manufacturing Practices (May 6)
• FDA and the National Alliance for Hispanic Health Announce New Efforts to Improve Access to Accurate Bilingual Health Information (May 5)
• Statement on Texas Cow With Central Nervous System Symptoms (May 4)
• FDA Approves First Insulin Drug for Diabetic Dogs (May 4)
• Agency Guidances Promote Comprehensive Efforts to Minimize Risks While Preserving the Benefits of Medical Products (May 4)

April 2004

• FDA Requires Pancreatic Extract Manufacturers to Submit Marketing Applications (April 27)
• FDA Proposes Additional Rules to Ensure the Safety of Imported Food (April 26)
• Couple Indicted for $1.5 Million Fraud Scheme(DoJ release (April 21, 2004)
• Statement on Cosmetic Exports to China (April 21)
• Acting FDA Commissioner Dr. Lester M. Crawford Outlines Science-Based Plan for Dietary Supplement Enforcement (April 19)
• Patrick Ronan Appointed New Head of FDA's Office of Legislation (April 15)
• Council on Family Health Offers Medicine Use Information for Seniors (CFH, April 14)
• FDA Partners with States to Warn Consumers that "Looks Can Be Deceiving" (April 13)
• Repackager of Foreign Drugs Agrees to Comply with FDA’s Rules (April 13)
• Dr. Barbara O. Schneeman Named To Lead FDA's Center for Food Safety and Applied Nutrition’s Office of Nutritional Products, Labeling, and Dietary Supplements (April 12)
• FDA Announces Rule Prohibiting Sale of Dietary Supplements Containing Ephedrine Alkaloids Effective April 12 (April 12)
• FDA Expands Warning About "Green Hornet" To Include All Other Products By Cytotec Solutions, Inc. (April 9)
• FDA Advises Parents about Lead in Mexican Candy (English) (Spanish) (April 9)
• Foodborne Illness Guide for Health Care Professionals Released (April 7)
• FDA Responds to the Use of Illegal Hormone Implants In Veal Calves (April 2)
• FDA Warns Supplement Firms about False Weight Loss Claims (April 1)

March 2004

• FDA Moves Forward on Qualified Health Claims (March 31)
• Aloe Commodities International, Inc., Recalls Solutions IE Ageless Formula II Due to Excess Vitamin D (March 26)
• NIH and FDA Launch New Human Gene Transfer Research Data System (NIH/FDA release, March 26)
• FDA Approves First Oral Fluid Based Rapid HIV Test Kit (March 26)
• FDA Enhances Safeguards For Consumers Who May Have Special Sensitivities to Certain Commonly Used Over-the-Counter Drug Ingredients (March 25)
• FDA Releases Acrylamide Data and Final Acrylamide Action Plan (March 25)
• Statement on Generic Oxycodone Hydrochloride Extended Release Tablets (March 23)
• FDA and EPA Announce the Revised Consumer Advisory on Methylmercury in Fish (March 19)
• Dietary Supplement Firms, Seasilver USA, Inc. and Americaloe, Inc., Sign Consent Decree (March 17)
• FDA and the U.S. Attorney for the Western District of Texas Announce Guilty Plea in Drug Counterfeiting Case (March 17)
• Report Seeks to Improve "Critical Path" of Medical Product Development (March 16)
• HHS Unveils FDA Strategy to Help Reduce Obesity (HHS Release, March 12)
• Statement by Tommy G. Thompson Secretary of Health and Human Services Regarding Confirmation of Mark B. McClellan to Lead CMS (HHS Release, March 12)
• HHS Launches Crackdown on Products Containing Andro (HHS release, March 11)
• FDA Commends Senate Passage of Bill Providing Improved Consumer Protection and Incentives for Animal Drug Development (March 9)
• FDA Issues Recommendations on Development of Drugs to Treat Side Effects of Vaccination Against Smallpox (March 8)
• FDA Announces Nationwide Recall of Faulty Patients Lifts (March 4)
• FDA Launches New Easy-to-Use Drug Information Web Site (March 3)
• FDA Announces Measures to Improve Generic Drug Access (March 2)
• U.S. Drug Prevention, Treatment, Enforcement Agencies Take on "Doctor Shoppers," "Pill Mills" (White House Release, March 1)

February 2004

• FDA Posts New Web Site on Heart Disease (February 27)
• Canada, Mexico and United States Sign Charter (February 27)
• HHS Announces Task Force on Drug Importation (DHHS Release, February 26)
• FDA Approves First Angiogenesis Inhibitor to Treat Colorectal Cancer (February 26)
• FDA Warns Consumers Not to Purchase Green Hornet, Promoted as Herbal Version of "Ecstasy" (February 25)
• HHS Announces New Requirements for Bar Codes on Drugs and Blood to Reduce Risks of Medication Errors (DHHS release, February 25)
• Pres. Bush to Nominate FDA Commissioner McClellan to Head Medicare Agency (White House release, February 20)
• FDA Issues Warning Letter to West Virginia Business Offering Illegal Foreign Drugs (February 20)
• HHS Takes New Steps to Protect Consumers from Counterfeit Drug Threats (DHHS Release, February 18)
• FDA Approves Erbitux for Colorectal Cancer (February 12)
• FDA Takes Action Against Foreign Websites Selling Counterfeit Contraceptive Patches (February 12)
• FDA Updates Hormone Therapy Information for Post Menopausal Women (February 10)
• FDA Issues Regulation Prohibiting Sale of Dietary Supplements Containing Ephedrine Alkaloids and Reiterates Its Advice That Consumers Stop Using These Products (February 6)
• FDA Seizes Ephedra-Containing Dietary Supplements From On-Line Massachusetts Company for Unsubstantiated Athletic Performance Claims (February 5)
• FDA and SEC Work to Enhance Public's Protection from False and Misleading Statements (February 5)
• FDA Approves First Drug for Rare Type of Cancer (February 5)
• FDA and Johnson and Johnson Warn Public About Counterfeit Contraceptive Patches Sold Through Foreign Internet Site (February 4)
• New FDA Draft Guidances Aim to Improve Health Information (February 4)
• FDA's Budget Proposal for FY 2005 Requests Increase for Food Safety (February 2)
• President Requests Budgetary Increase, Greater Food Defense Role for FDA in FY 2005 (February 2)
• FDA Names David W.K. Acheson, M.D., Director of the Food Safety and Security Staff (February 2)

January 2004

• President Proposes Increase in Medical Device Budget for FY 2005 (January 30)
• Recent FDA/U.S. Customs Import Blitz Exams Continue to Reveal Potentially Dangerous Illegally Imported Drug Shipments (January 27)
• FDA Issues Draft Guidance on Providing More Information on Investigational Treatment (January 27)
• Expanded 'Mad Cow' Safeguards Announced (DHHS, January 26)
• FDA Warns Consumers Not to Feed Infants “Better than Formula Ultra Infant Immune Booster 117” (January 23)
• FDA Launches Consumer Campaign on Safe Use of OTC Pain Products (January 22)
• Broader Requirements for Tissue Bank Registration and Listing Become Effective Today (January 21)
• Statement on FDA's Participation in U.S. Government's Delegation to Japan and Korea on BSE (January 16)
• FDA Sees Rebound in Approval of Innovative Drugs in 2003: New Innovation Initiative Anticipated to Speed Approvals in Years Ahead (January 15)
• FDA Advances Consumer Health and Safety in 2003 (January 13)
• FDA Provides Pathway for Sponsors Seeking Approval of Breast Implants (January 8)