FDA Talk Papers Archives

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2000

December 2000

• FDA Issues Safety Alert on Unapproved Goat Serum Treatment for HIV/AIDS (Dec. 22)
• FDA Approves New Treatment for Eczema (Dec. 8)

November 2000

• Scheme to Sell Gas Grill Igniters for Pain Relief Backfires; Court Orders Refund to Purchasers (Nov. 30)
• Glaxo Wellcome Decides to Withdraw Lotronex From the Market (Nov. 28)
• FDA Warns Against Consuming Dietary Supplements Containing Tiratricol (Nov. 21)
• FDA Approves Tamiflu for Another Indication--Prevention of Influenza (Nov. 20)
• Christian Brothers Contracting Corporation Signs Consent Decree With FDA; Agrees To Stop Selling All Amygdalin/Laetrile Products (Nov. 17)
• FDA Approves New Device to Help Distinguish Harmless from Pre-Cancerous Growths in Colon (Nov. 15)
• FDA Approves Trizivir for HIV (Nov. 15)
• FDA Approves Two New Devices to Help Reduce the Risk of Repeat Coronary Stent Re-Narrowing (In-Stent Restenosis) (Nov. 6)
• FDA Issues Public Health Warning on Phenylpropanolamine (Nov. 6)
• FDA Announces Decision on Another Health Claim for Dietary Supplements (Nov. 2)

October 2000

• FDA Approves New Implanted Hearing Device (Oct. 23)
• FDA Announces Food Safety Grants (Oct. 16)
• FDA Report on New Medical Devices Approved in FY 2000 (Oct. 16)
• FDA Approves Novantrone for Treating Advanced Multiple Sclerosis (Oct. 13)
• FDA Approves Shock Wave Device for Severe Heel Pain (Oct. 12)
• FDA Announces Decision on Two Health Claims for Dietary Supplements (Oct. 11)
• vU.S. District Court Dismisses Genetically Engineered Food Law Suit Against FDA (Oct. 6) v
• FDA Approves Altace for Reducing Risk of Heart Problems (Oct. 6)
• Wyeth-Ayerst Laboratories Signs Consent Decree with FDA (Oct. 3)

September 2000

• FDA Approves Arsenic Trioxide for Leukemia Treatment in Record Time for a Cancer Drug Development (Sept. 26)
• FDA Approves New Glue for Use in Brain Surgery (Sept. 26)
• FDA Proposes New Guidance for Apnea Monitors (Sept. 21)
• FDA Launches National Food Safety Education Month Efforts (Sept. 21)
• FDA Approves Kaletra for HIV Infection (Sept. 15)
• Update of Advisory for Several Lots of Norplant Contraceptive Kits (Sept. 13)
• FDA Database of Foodborne Illness Risk Factors Released (Sept. 7)
• FDA Authorizes New Coronary Heart Disease Health Claim for Plant Sterol and Plant Stenol Esters (Sept. 5)
• FDA Takes Action Against Firms Marketing Unapproved Drugs (Sept. 6)

August 2000

• FDA Approves New Implanted Hearing Device (Aug. 31)
• Approval of Cipro® for Use After Exposure to Inhalational Anthrax (Aug. 31)
• FDA Approves First NDA for Levothyroxine Sodium (Aug. 22)
• FDA Approves Pulmicort Respules for Asthma (Aug. 8)
• FDA Issues Final Guidance on Reuse of Single-Use Medical Devices (Aug. 2)

July 2000

• FDA Approves Malarone for the Prevention and Treatment of Malaria (July 14)
• Nationwide Recall of SangCya Oral Solution (July 10)
• FDA Approves Fluoxetine to Treat Premenstrual Dysphoric Disorder (July 6)

June 2000

• Guidance for Adverse Reactions Labeling (June 23)
• FDA Approves New Product for Diabetic Foot Ulcers (June 20)
• California IVD Firm Signs Consent Decree With FDA; Agrees to Stop Manufacturing, Correct Violations (June 19)
• FDA and CTIA to Collaborate on Cell Phone Research (June 8)
• Sunscreen Regulations Updater (June 8)

May 2000

• FDA Approves New Surgical Sealant for Lung Cancer (May 30)
• FDA Advises Consumers About Fresh Produce Safety (May 26)
• FDA Approves New Cancer Drug (May 18)
• Federal Grand Jury Indicts Alleged Operator of an Illegal Internet Drug Operation (May 17)
• FDA Approves New Fetal Oxygen Saturation Monitor (May 15)
• Illegal Oxygen Transfilling Operation Pleads Guilty to FDA Charges (May 10)
• FDA Clears New Female Sexual Therapy Device (May 3)

April 2000

• FDA Approves Camptosar for First-Line Therapy in Treatment of Advanced Colorectal Cancer (April 21)
• FDA Approves Zyvox, the First Antimicrobial Drug in a New Class (April 18)
• FDA Issues Warning on TriCitrasol Dialysis Catheter Anticoagulant (April 14)

March 2000

• FDA Announces the Availability of New Ephedrine and "Street Drug Alternative" Documents (March 31)
• Janssen Pharmaceutica Stops Marketing Cisapride in the U.S. (March 23)
• FDA's Law Enforcement in FY 1999 (March 8)

February 2000

• FDA Issues Approvable Letter for Mifepristone (Feb. 18)
• FDA Training Programs Honored with Communications Awards (Feb. 17)
• FDA Approves Irritable Bowel Syndrome Treatment for Women (Feb. 9)
• New Year's Budget Request for FDA (Feb. 7)
• FDA Launches "Cyber" Letters Against Potentially Illegal Foreign-Based Online Drug Sites (Feb. 2)

January 2000

• FDA Approves First Digital Mammography System (Jan. 31)
• FDA Updates Warnings for Cisapride (Jan. 24)
• FDA's Report on New Health Care Products Approved in 1999 (Jan. 18)
• Dairy Operator Pleads Guilty to Criminal Charges (Jan. 14)
• FDA Reminds Prescribers of Important Considerations Before Prescribing Flu Drugs (Jan. 12)
• Presidential Rank Award Bestowed to Five Top FDA Officials (Jan. 6)
• FDA Finalizes Rules for Claims on Dietary Supplements (Jan. 5)

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