FDA Press Releases Archives

2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 | 1996 | 1995 | 1994 | 1993 | 1992

2003

December 2003

• FDA Issues Final Rule and Final Order Regarding Safety and Efficacy of Certain Licensed Biological Products Including Anthrax Vaccine (December 30, 2003)
• FDA Statement on Rendered Products Derived From BSE Cow in Washington State (December 27, 2003)
• Statement of Probable Case of BSE in Washington State (December 24, 2003)
• FDA Approves Lab Tests for Genetic Clotting Risk (December 17, 2003)
• Pet Turtles Pose Risk of Salmonella Infection for Infants and Small Children (December 15)
• FDA Honors W. Leigh Thompson, M.D., Ph.D. for His Outstanding Contributions to Medicine and the Public Health (December 12)
• FDA and CBP Define Their Transitional Compliance Policy on Food Imports Under the Bioterrorism Act (December 11)
• FDA Statement Regarding Glofish (December 9)
• FDA Update on Recent Hepatitis A Outbreaks Associated With Green Onions From Mexico (December 9)
• FDA Clears Lab Culture Test for Anthrax (December 9)
• FDA Publishes New Requirements for E-Labeling of Drug and Biologics Application (December 9)
• FDA Converts Gleevec in Second Line Setting to Regular Approval (December 8)
• Statement of the FDA Commissioner Mark B. McClellan, M.D., Ph.D., on the signing of the Pediatric Research Equity Act of 2003 (December 3)
• FDA and CPB Bolster Safeguards on Imported Food (December 3)
• FDA Updates and Clarifies Draft Guidance to Industry on Drugs of Abuse Screening Tests (December 2)
• Joseph A. Levitt Retires as Director of FDA’s Center for Food Safety and Applied Nutrition; Dr. Robert E. Brackett to Succeed Him (December 1)

November 2003

• United States Seizes Contaminated Food Articles at Northeast, Washington, D.C. Food Distributor (DOJ/FDA Release, November 28)
• Consumers in Oregon Area Advised of Risks Associated with Raw Sprouts (November 26)
• Statement on U.S. Court of Appeals Decision Denying a Stay on RxDepot Decision (November 24)
• Commissioner of Food and Drugs Applauds Senate Action on Public Health Measures (November 24)
• Statement on Hepatitis A (November 21)
• HHS Secretary, FDA Commissioner Commend Passage of Pediatric Research Act (November 19)
• President Signs New Law Providing User Fees to Improve Animal Drug Review (November 19)
• FDA’s Dr. Christine Taylor to Lead Special Nutrition Project for World Health Organization (November 12, 2003)
• NCI, FDA Announce Joint Cancer Treatment Initiatives (November 12)
• Royal Tongan Limu Dietary Supplements Promoted to Treat Various Diseases Destroyed (November 10)
• Food and Drug Administration Alerts Boaters Not to Use Certain Baltimore Harbor Watering Points (November 10)
• Statement of Dr. Mark McClellan, Commissioner of Food and Drugs regarding Bipartisan Congressional approval of the “Animal Drug User Fee Act of 2003” (November 7)
• FDA Statement on RX Depot Decision (November 6)
• CanaRX Illegally Supplying Prescription Drugs; Company Violates U.S. Law, Puts Americans at Risk (November 6)
• Louisiana Ophthalmologist Fined $1.1 Million by FDA for Clinical Study Violations (November 5)
• FDAíS Office of Women's Health Awards 5-Year Research Contracts (November 5)
• Interim Rule to Prevent Transmission of Monkeypox (November 3)
• FDA Issues Guidance on Pharmacogenomics Data (November 3)

October 2003

• FDA Issues Draft Executive Summary of its Assessment of Safety of Animal Cloning (October 31)
• FDA Statement on THG (October 28)
• FDA Commissioner and Deputy Commissioner Elected Members of Institute of Medicine (October 27)
• A Milestone for ClinicalTrials.gov Web Site (October 27)
• FDA Issues Guidance on Evaluating the Safety of Antimicrobial New Animal Drugs to Help Prevent Creating New Resistant Bacteria (October 23)
• Risk Assessment Reinforces That Keeping Ready-To-Eat Foods Cold May be the Key to Reducing Listeriosis (October 21, 2003)
• FDA Proposes Steps to Assure the Safety and Efficacy of Certain Currently Unapproved Medicines (October 17, 2003)
• FDA Approves Memantine (Namenda) for Alzheimer's Disease (October 17, 2003)
• FDA Introduces New Technology to Improve Food Security: Electronic Food Facility Registration Goes "Live," Allowing More Than 400,000 Facilities to Register in Minutes; FDA Reports on Progress in Developing Rapid Tests of Food Contamination (October 16, 2003)
• FDA and AoA Focus Disease Prevention Initiative Toward Older Hispanic Americans (October 15)
• FDA Commissioner Mark McClellan Addresses Public Meeting on Strategies to Combat Counterfeit Drugs, Previews Promising Anti-Counterfeit Technologies (October 14)
• FDA Statement on Foodborne Illness Risk Assessment (October 13)
• Misys Healthcare Systems Issues Nationwide Recall of B-AUT-RAPID-LAB Software (October 10)
• FDA Warns Consumers Not to Use Decorative Contact Lenses Without Proper Professional Involvement (October 10)
• Margaret OíK. Glavin Appointed FDAís Assistant Commissioner For Counter-terrorism (October 10)
• HHS Issues New Rules to Enhance Security of the U.S. Food Supply (DHHS, October 9, 2003)
• FDA Stops Sale and Distribution of Dietary Supplements Making Misleading Claims About Obesity and Impotence (October 8)
• FDA Public Meeting on Obesity (October 7)
• Statement by Secretary of Health and Human Services Tommy G. Thompson and Commissioner of Food and Drugs Mark B. McClellan, M.D., Ph.D. Praising House Passage pf H.R. 1260, “The Animal Drug User Fee Act Of 2003 (October 2)
• FDA Approves First New Drug Application for Treatment of Radiation Contamination due to Cesium or Thallium (October 2)
• FDA Anti-Counterfeiting Task Force Interim Report Focuses on High-Tech Weapons and Other Promising New Counter Measures (October 2)

September 2003

• FDA/U.S. Customs Import Blitz Exams Reveal Hundreds of Potentially Dangerous Imported Drug Shipments (September 29)
• FDA Seizes Bogus Dietary Supplement That Claims to Cure Cancer (September 18)
• HHS, Public Health Partners Unveil New Campaign to Promote Awareness of Proper Antibiotic Use (DHHS Release, Sept. 17)
• FDA Warns CanaRx Its Drug Importing is Illegal (September 16)
• FDA Initiates Seizure of Potentially Dangerous Drugs From Repackager (September 15)
• FDA Encourages New Applications for Drugs to Treat Internal Contamination from Radioactive Elements (September 12)
• FDA Warns Milk Producers to Remove "Hormone Free" Claims From the Labeling Of Dairy Products (September 12)
• Statement of Dr. Mark McClellan, Commissioner of Food and Drugs regarding House Energy and Commerce Committee approval of H.R. 1260, the "Animal Drug User Fee Act of 2003." (September 10)
• FDA Issues Advisory on Star Anise "Teas" (September 10)
• FDA Issues Warning Letter to Internet Companies Selling Dangerous, Unapproved Drug Without Prescription (September 9)
• FDA Takes Action Against Companies That are Importing Unapproved, Potentially Unsafe Drugs (September 9)
• FDA Launches Collaborative Campaign to Inform Women About Menopausal Hormone Therapy (September 9)
• FDA to Announce Initiative to Provide Better Health Information for Women on Menopausal Hormone Therapy (September 8)
• FDA Announces Progress Toward "21st Century" Regulation of Pharmaceutical Manufacturing (September 3)

August 2003

• Physician, Pharmacists Indicted for Illegally Dispensing Rx Drugs (DOJ release, August 26, 2003)
• Lactoferrin Considered Safe to Fight E. Coli (August 22)
• FDA Unveils 5-Part Strategic Action Plan To "Protect and Advance America's Health" (August 20)
• FDA Approves Stair-Climbing Wheelchair (August 13)
• FDA's New Regulation to Speed Access to Lower Cost Generic Drugs About to Take Effect (August 8)
• Device Firm Signs Consent Decree, Agrees to Fix Reprocessing Problems (August 7)
• Las Vegas Man Pleads Guilty to Unlawful Distribution of Controlled Substances on the Internet (DOJ Release August 5)
• FDA Announces New Goal for Reducing Total Device Review Times (August 5)

July 2003

• Statement from FDA Commissioner Mark B. McClellan, M.D. on FDA Public Meeting to Discuss Written Prescription Information for Consumers (July 31, 2003)
• Senate Passes Pediatric Research Equity Act (HHS Statement, July 24)
• HHS Creates Food Security Research Program, Increases Import Exams More Than Five Times to Protect Nation's Food Supply (HHS Release, July 23)
• President of Queens Firm Found Guilty of Criminal Contempt For Violating Court Order Not to Market Bogus Cancer Cure Over the Internet (DOJ Release, July 22)
• FDA Announces Initiative to Heighten Battle Against Counterfeit Drugs (July 16)
• FDA to Review Ways to Reduce the Risk of Contamination Involving the Processing of Food (July 15)
• U.S. Department of Justice Files Consent Decree Of Permanent Injunction Against X-Cel Feeds, Inc. Based on Violations of FDA’s 1997 Animal Feed Rule (July 11)
• FDA to Encourage Science-based Labeling and Competition for Healthier Dietary Choices(July 10)
• Former Pharmacy Employee Convicted in Illegal Drug Distribution Scheme (July 9)
• FDA Creates Medication Guide for Lariam (July 9)
• HHS to Require Food Labels to Include Trans Fat Contents (HHS Release, July 9)
• FDA Clears First Test for West Nile Virus (July 9)
• Cordis Corporation Issues a Health Care Professional Letter Regarding the CYPHER Stent (July 8)
• FDA Clears New Diabetes Device for Marketing (July 7)

June 2003

• FDA Aproves Prilosec OTC to Treat Frequent Heartburn (June 20)
• Federal Investigation Leads to Guilty Plea in Healthcare Crime (June 20)
• Woman Sentenced for Falsely Promoting Cure for Spinal Injuries (June 18)
• The U.S. and Mexico Sign a Memorandum of Understanding Enhancing the Safety and Quality of Shellfish (June 18) (Spanish)
• First Nasal Mist Flu Vaccine Approved (June 17)
• HHS Revises Regulations and Procedures to Speed Access to Generic Drugs (June 12) -- HHS Release
• FDA, FTC Take Action Against Coral Calcium Sellers (June 10)(FDA/FTC)

May 2003

• NCI and FDA Announce Joint Program to Streamline Cancer Drug Development (May 30)
• FDA and Bureau of Customs and Border Protection Announce Steps to Streamline Collection of Information on Food Imports (May 27)
• Pet Pantry Pet Food May Contain BSE (May 26)
• FDA Approves Gleevec for Pediatric Leukemia Treatment (May 21)
• Statement on BSE Cow in Alberta, Canada (May 20)
• FDA Clears Rapid Test for Aspergillus Infection (May 16)
• FDA Approves Lower Cost Implantable Defibrillator (May 15)
• FDA Approves Velcade for Multiple Myeloma Treatment (May 13)
• FDA, FTC Crack Down on Bogus Internet SARS Products (May 9)
• FDA Seeks Injunction Against Multidata Systems Intl. (May 7)
• FDA Issues Final Two Proposed Food Safety Regulations (May 6)
• FDA Approves New Type of Drug for Lung Cancer (May 5)
• FDA, National Alliance for Hispanic Health to Improve Access to Agency Health Information (May 2)
  Spanish | English
• FDA, Lincoln Technologies to Use Adverse Event 'Data Mining' to Improve Patient Safety (May 1)

April 2003

• Misbranded 'Nature's Youth hGH' Supplements Destroyed (April 30)
• FDA Approves First Treatment for Fabry Disease (April 24)
• FDA Approves Drug-Eluting Stent for Clogged Heart Arteries (April 24)
• Update: Secretary Thompson to Speak at FDA Science Forum (April 22)
• FDA Commends Drug Industry Commitment to Report Counterfeit Drugs (April 22)
• FDA Plans to Withdraw Outdated Draft Proposals (April 21)
• Peter J. Pitts Appointed Associate FDA Commissioner for External Relations (April 21)
• American Red Cross Agrees to Revised Consent Decree to Improve Blood Safety (April 11)

March 2003

• FDA Approves Expanded Use of HPV Test (March 31)
• FDA Acts Against Potentially Risky Products Illegally Marketed as Street Drug Alternatives (March 31)
• FDA Clears Skin Lotion for Military to Protect Against Chemical Burns (March 28)
• FDA Strongly Supports Oklahoma Action Against Storefront Pharmacy (March 27)
• FDA Approves New Drug to Combat Nausea and Vomiting for Cancer Patients Getting Chemotherapy (March 26)
• FDA Approves First in a New Class of Medicines To Treat Acromegaly (March 26)
• Reiter Dairy Recalls Chocolate Milk Due to Excess Vitamins A and D (March 21)
• FDA Asks HHS Inspector General to Investigate FDA-Sponsored Clinical Trial (March 21)
• FDA Collaborates with Arkansas State Board of Pharmacy in Enforcement Action Against Storefront Obtaining Unapproved Drugs from Canada (March 21)
• FDA Issues New Security Guidance as Part of Operation LibertyShield to Protect the Food Supply (March 19)
• FDA Completes Final Phase of Planning for Consolidation of Certain Products from CBER to CDER (March 17)
• FDA Approves First Drug in New Class of HIV Treatments (March 13)
• FDA Approves Lower Dose of Menopausal Drug Prempro (March 13)
• Secretary Thompson Announces Steps to Reduce Medication Errors (March 13) -- HHS Release
• FDA Statement on Counterfeit Procrit (March 11)
• FDA Proposes Labeling and Manufacturing Standards for All Dietary Supplements (March 7)

February 2003

• HHS Acts to Reduce Potential Risks of Dietary Supplements Containing Ephedra (February 28)
• Update on FDA's Continuing Investigation of Particulate Matter in Blood Shows Normal Blood Components and No Evidence for an Increase in Adverse Events (February 27)
• Statement of Dr. Mark McClellan, Commissioner of Food and Drugs on Approval of the Omnibus Appropriation Bill (February 24)
• FDA Completes First Steps of its Broad Initiative to Improve Regulation of Pharmaceutical Manufacturing (February 20)
• FDA Seizes Dietary Supplements (February 13)
• FDA Approves Pyridostigmine Bromide as Pretreatment Against Nerve Gas (February 5)
• FDA Publishes Final Rule to Require Labeling About Antibiotic Resistance (February 5)

January 2003

• HHS Extends Use of Rapid HIV Test to New Sites Nationwide (HHS Release January 31)
• Firms that Make Treatment for Radiation Exposure Encouraged to Apply to FDA (January 31)
• FDA Launches Initiative to Improve the Development and Availability of Innovative Medical Products (January 31)
• Prior Notice of Imported Food Shipments Proposal (January 29)
• FDA Proposes Regulation for Registering Food Facilities (January 29)
• FDA Task Force on Consumer Health Information for Better Nutrition Established (January 16)
• FDA Approves New Labels for Estrogen and Estrogen with Progestin Therapies for Postmenopausal Women Following Review of Women's Health Initiative Data (January 8)

Top