FDA Press Releases

2004

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

December 2004

• FDA Clears First of Kind Genetic Lab Test (December 23)
• FDA Statement on Naproxen (December 20)
• FDA Statement on Celebrex DTC Promotion (December 20)
• FDA Approves New Drug Treatment for Age-Related Macular Degeneration (December 20)
• FDA Statement on Iressa (December 17)
• FDA Statement on the Halting of a Clinical Trial of the Cox-2 Inhibitor Celebrex (December 17)
• New Jersey Man Arrested for Illegal Importation of Unapproved Flu Vaccine (Criminal Complaint) (U.S. Immigration and Customs Enforcement release) (December 6)
• FDA Issues Final Rule on the Establishment and Maintenance of Records to Enhance the Security of the U.S. Food Supply Under the Bioterrorism Act (December 6)
• FDA Takes Action Against Company for Illegal Importation of Unapproved, Potentially Unsafe Drugs (December 1)

November 2004

• First Monoclonal Antibody Treatment For Multiple Sclerosis Approved (November 23, 2004)
• FDA Acts to Remove Ephedra-Containing Dietary Supplements From Market (November 23, 2004)
• FDA Approves New Drug for the Most Common Type of Lung Cancer (November 19)
• Statement by Dr. Steven Galson, Acting Director, Center for Drug Evaluation and Research (CDER), Regarding November 18, 2004, Committee on Finance of the U.S. Senate Hearing on Drug Safety and the Worldwide Withdrawal by Merck & Co., Inc., of Vioxx (November 18)
• FDA Improves the Safety of Human Cells and Tissues by Finalizing New Rules for "Good Tissue Practice" (November 18)
• FDA Statement on Vioxx and Recent Allegations and the Agency’s Continued Commitment to Sound Science and Peer Review (November 17)
• Statement of Dr. Lester M. Crawford, Acting Commissioner of Food and Drugs on the Resignation of Daniel E. Troy (November 16)
• FDA To Announce Important Labeling Changes for Mifepristone (November 15)
• FDA Announces New Initiative to Protect the U.S. Drug Supply Through the Use Of Radiofrequency Identification Technology (November 15)
• Sentence Ordered in Drug Counterfeiting Case (November 9)
• 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)

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)