FDA Talk Papers Archives

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2001

December 2001

• New Advisory Subcommittee Created on Drug Safety and Risk Management (December 18)
• FDA's Guidance on Protection of Children and Adults Against Thyroid Cancer in Case of Nuclear Accident (December 10)
• FDA Approves New Anti-Clotting Drug (December 10)
• FDA Approves Two New Medical Devices to Treat Congenital Heart Defects (December 6)
• FDA Strengthens Warnings for Droperidol (December 5)
• Maryland Businessman Sentenced for Illegally Marketing Aloe Vera Compounds as AIDS and Cancer Treatments (December 5)

November 2001

• FDA Approves First Oral Medication for Pulmonary Arterial Hypertension (November 20)
• FDA Warns Consumers Not to Use the Dietary Supplement Lipokinetix (November 20)
• FDA Approves First Hormonal Contraceptive Skin Patch (November 20)
• FDA, VA Join to Study HIV Drug Effect
  (November 20)
  
• FDA Approves New Anti-Adhesion Treatment for Gynecologic Surgery (November 19)
• FDA's Food Safety Video Wins Emmy Award (November 15)
• FDA Issues Cyber-Letters to Web Sites Selling Unapproved Foreign Ciprofloxacin (November 1)

October 2001

• U.S. Marshals Seize Unapproved Drug in FDA Case (October 31)
• FDA Announces Changes to the Risk Management Program to Prevent Birth Defects Caused by Accutane (October 31)
• FDA Encourages Drug Firms to Revise Doxycycline and Penicillin G Procaine Labeling with Information for Treating Inhalational Anthrax (Post-Exposure) (October 30)
• FDA Approves Viread for HIV-1 Infection (October 29)
• FDA Enhances Its Ability to Monitor Marketed Medicines (October 17)
• FDA Approves 30-Night Continuous Wear Contact Lenses (October 12)
• FDA Approves New Type of Pacemaker (October 11)
• FDA Approves First Hormonal Vaginal Contraceptive Ring (October 3)
• FDA Approves New Treatment for Crohn's Disease (October 3)
• FDA Announces Food Safety Grants (October 2)

September 2001

• FDA Funds Research on Prescription Medications Used by Pregnant Women (September 28)
• FDA Approves First Nucleic Acid Test (NAT) Systems to Screen Plasma for Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) (September 21)
• Hip Implants Being Recalled; Potential Fracture Problem (September 14)
• FDA Approves Xeloda in Combination with Taxotere for Advanced Breast Cancer (September 10)

August 2001

• FDA Approves First Pacemaker for Congestive Heart Failure (August 28)
• FDA Warns Consumers About Imported Jelly Cup Type Candy That Poses a Potential Choking Hazard (August 17)
• FDA Actions on Reprocessed Single-Use Devices (August 16)
• FDA Approves Acute Congestive Heart Failure Treatment (August 13)
• FDA Approves New Labeling for PEG-Intron for Use with Rebetol (August 8)
• Bayer Voluntarily Withdraws Baycol (August 8)
• FDA Clears Camera Pill to Photograph Small Intestine (August 1)

July 2001

• Strict Prison Sentence Given to Owner of Illegal Dairy Operation (July 30)
• FDA Approves Stand-Alone Package of Ribavirin for Combination Therapy with Intron A for Treatment of Chronic Hepatitis Infection (July 26)
• FDA Strengthens Warnings for OxyContin (July 25)
• FDA Approves First Drug to Treat Serious Neurological Disease in Horses (July 19)
• FDA Issues Guidance on Levothyroxine Sodium Products Compliance (July 12)

June 2001

• FDA Approves First Injectable Heartworm Drug for Dogs(June 7)
• FDA Approves Implanted Stomach Band to Treat Severe Obesity (June 5)
• Catheter Device Could Benefit Thousands of Heart Patients (June 1)

May 2001

• Elan Pharmaceuticals Subsidiary Signs Consent Decree with FDA (May 21)
• New Combination Vaccine Approved for Protection Against Two Hepatitis Viruses (May 14)
• FDA Issues Health Advisory Regarding the Safety of Sporanox® Products and Lamisil® Tablets to Treat Fungal Nail Infections (May 9)
• FDA Clears First External Defibrillator for Use on Young Children (May 4)

April 2001

• Solgar Vitamin And Herb Company Recalls Solgar's Digestive Aid 100's Dietary Supplements Because Of Possible Salmonella Contamination (April 26)
• FDA and Canadian Food Inspection Agency Warn Against Consuming Mislabeled Poisonous Plant Called Autumn Monkshood (April 25)
• FDA Alerts Public to Possible Health Risk Associated with Certain Tamarind Candy Lollipops from Mexico (April 25) English Spanish
• FDA Issues New Requirements For Bolstering Child Protection in Clinical Trials (April 20)
• FDA Announces Labeling Changes Following Cardiac Adverse Events With Addiction Drug (April 20, 2001
• FDA Approves Second Non CFC-Containing Albuterol Inhaler (April 20)
• Irradiation of Animal Feed (April 10)
• FDA's Budget Request for FY 2002 (April 9)

March 2001

• Injectable Anesthesia Drug Being Withdrawn from Market (March 29)
• FDA Updates Safety Information for Miconazole Vaginal Cream and Suppositories (March 5)

February 2001

• FDA Issues Letter to Industry on Foods Containing Botanical and Other Novel Ingredients (Feb. 5)

January 2001

• FDA Approves New Treatment for Invasive Fungal Infection (Jan. 29)
• FDA Announces Report on Safety of Imported Foods (Jan. 19)
• FDA Announces Availability of Vibrio Parahaemolyticus Risk Assessment (Jan. 18)
• FDA's Report on New Health Care Products Approved in 2000 (Jan. 18)
• FDA Announces Advisory on Methyl Mercury in Fish (Jan. 12)
• FDA Approves Femara as First-Line Therapy for Advanced Breast Cancer (Jan. 10)
• FDA/Bristol Myers Squibb Issues Caution for HIV Combination Therapy With Zerit and Videx in Pregnant Women (Jan. 5)
• FDA Proposes New Rules for "Good Tissue Practice" (Jan. 5, 2001

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