FDA Talk Papers Archives

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2003

December 2003

• FDA Investigating Reports of Unlicensed Infuenza Vaccine (December 23, 2003)
• FDA Issues Alert on Counterfeit Polypropylene Mesh Used in Hernia Repair (December 19)
• FDA Issues Safety Tips for Preventing Hospital Bed Fires (December 18)
• FDA Updates Physicians on Mortality Risks Associated with Aneurx Stent Graft System (December 17)
• FDA Approves New Product for Facial Wrinkles (December 12)
• FDA Announces Comprehensive Foods Advisory on Methylmercury (December 10)
• FDA Meets with Stakeholders to Address Issues Related to the Implementation of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (December 3)

November 2003

• FDA Approves New Drug for Advanced Prostate Cancer (November 25)
• FDA Updates Information for Physicians on Cordis Cypher Stent (November 25)
• FDA Seeks Comments on Managing Qualified Health Claims (November 21)
• FDA Approves Third Drug To Treat Erectile Dysfunction (November 21)
• Scientific Workshop on "Exploring the Link Between Weight Management and Food Labels and Packaging" November 20, 2003 (November 19)
• FDA Tips to Prevent Foodborne Illness This Holiday Season (November 18)
• FDA Advises Consumers That Recent Hepatitis A Outbreaks Have Been Associated With Raw or Lightly Cooked Green Onions (November 15)
• FDA Alerts U.S. Residents to Recall of Glaxo Smith Kline "Diskus" Asthma Medicines Sold in Canada (November 14)
• FDA Approves Ovcon 35 as the First Chewable Oral Contraceptive Tablet for Women (November 14)
• FDA Statement on Reported Health Problems With Remedia-Brand Kosher Soy-Based Infant Formula (November 10)

October 2003

• FDA Collaborates with AOAC to Gain Approval of Peanut Test Kits for Food Products (October 30)
• FDA Advises Physicians of Adverse Events Associated with Cordis Cypher Coronary Stents (October 29)
• FDA Issues Public Health Advisory Entitled: Reports Of Suicidality in Pediatric Patients Being Treated with Antidepressant Medications for Major Depressive Disorder (MDD) (October 27)
• FDA Approves Estrasorb For Treatment of Menopausal Hot Flashes (October 10)
• FDA Approves Inspra for Improving Survival of Congestive Heart Failure Patients After a Heart Attack (October 8)
• DA Warns Consumers About Use of "Litargirio" - Traditional Remedy That Contains Dangerous Levels of Lead (en español) (October 2)

September 2003

• FDA Approves First in New Class of Antibiotics (September 12)
• FDA Approves Seasonale Oral Contraceptive (September 5)

August 2003

• FDA Updates Labeling of Valtrex (August 29)
• FDA Approves New Drug for Treatment of Erectile Dysfunction in Men (August 19)
• Labeling Changes for Drug Products that Contain Salmeterol (August 14)
• FDA Approves New Drug for Lowering Cholesterol (August 12)
• FDA Approves Photofrin for Treatment of Precancerous Lesions in Barrett’s Esophagus (August 4)
• FDA Changes Labeling Requirement for Olestra (August 1)

July 2003

• FDA Announces Device User Fees for FY 2004 (July 31, 2003)
• FDA Proposes New Rules to Revise Blood Storage and Container Labeling Requirements (July 29)
• FDA Approves Humatrope for Short Stature (July 25)
• New Recombinant Antihemophilic Factor Licensed (July 25)
• FDA Approves Enbrel to Treat Ankylosing Spondylitis (July 24)
• FDA Clears New Lab Test to Help Predict Those at Risk of Coronary Heart Disease (July 18)
• Recall of Nortrel 7/7/7 Due to Mispackaging Causes Increased Chance of Pregnancy (July 11)

June 2003

• FDA Announces Pilot Program to Post Warning Letter Responses (June 23)
• FDA Approves First Biologic for Allergy-Related Asthma (June 20)
• FDA Warns Consumers Against Taking Some NVE, Inc. Supplements (June 20)
• Executives Indicted for Storing Food in Rodent-Infested Warehouse (June 20)
• FDA Approves a Once Daily Protease Inhibitor for HIV Infection (June 20)
• FDA Approves Pediatric Doses of Atropen (June 20)
• FDA/FTC Crack Down on Supplement Firms
• Update on the Consolidation of Certain Products from FDA's Center for Biologics to it's Center for Drugs (June 19)
• FDA Statement Regarding the Anti-Depressant Paxil for Pediatric Population (June 19)
• Counterfeit Lipitor Investigation Prompts New Recalls (June 17)
• FDA Discusses Pediatric Drug Safety with Advisory Panel (June 12)
• FDA's Continuing Investigation Implicates Additional Lots of Counterfeit Lipitor (June 3)

May 2003

• FDA: Cognitive Effects Study Warrants No Change in Use of Estrogen/Progestin (May 27)
• Commissioner's Statement on Senate Approval of Animal Drug User Fee Act (May 23)
• FDA Alerts Consumers and Health Professionals to Recall of Counterfeit Lipitor (May 23)
• Federal Register Report and FDA Web Site on Postmarketing Studies (May 22)
• FDA Assesses Irregularities Involving the Handling of Certain Unapproved Imported Viagra Products (May 20)
• FDA Approves First Injectable Solution for Chemical Sterilization in Dogs (May 19)
• FDA Issues Draft Guidance on Use of Material From Deer and Elk in Animal Feed (May 15)
• FDA Clears New Breath Test for Monitoring Asthma (May 1)

April 2003

• FDA Approves First Treatment for Rare Enzyme Disorder (April 30)
• FDA Statement on "Scientific Criteria to Ensure Safe Food," a Report by the National Academy of Sciences (April 25)
• FDA Approves Implant for Gastroesophageal Reflux Disease (April 22)
• FDA Issues Guidance on SARS to Further Safeguard the Blood Supply (April 17)
• FDA Science Forum Only One Week Away (April 17)
• FDA Announces Labeling Changes on Heart Benefits of Zocor (April 16)
• FDA Grants Expanded Use of Brain Implant for Movement Disorder (April 16)
• FDA Approves New Rapamune Labeling Likely to Improve Transplanted Kidney Functioning (April 11)
• FDA Revises Finding on Estrogen/Androgen Combination Products in the Treatment of Hot Flashes (April 10)
• FDA's Advisory on Methylmercury in Fish
• FDA Issues Draft Guidance on Potassium Iodide Shelf-Life Extension (April 1)
• McClellan to Headline FDA's 9th Annual Science Forum: Protecting America's Health (April 1)
• FDA Final Rule Streamlines Adverse Event Reporting for New Animal Drugs (April 1)

March 2003

• FDA Issues Health Advisory Regarding Labeling Changes for Lindane Products (March 28)
• FDA Warns Public About Misrepresentations in Marketing Claims About Drug to Treat Cancer (March 14)

February 2003

• Distribution of Dioxin-Contaminated Animal Feed Mineral Mixes and Feed Halted (February 28)
• FDA Advisory Committee Discusses Steps for Potentially Continuing Certain Gene Therapy Trials That Were Recently Placed on Hold (February 28)
• FDA Issues Letter Discussing its Enforcement Policy for Unapproved Drugs (February 26)
• FDA Clears New Lab Test to Help Rule Out Heart Attack (February 14)
• FDA Recommends Temporary Additional Blood Inspection Measures as it Continues Investigation of Reports of White Particulate Matter in Some Units of Blood and Blood Components (February 7)
• United States Seeks Injunction Against a Baltimore, Maryland Food Processing and Distribution Facility (February 6)
• FDA Investigates Improper Disposal of Bioengineered Pigs (February 5)
• FDA Seizes Adulterated Honey (February 5)
• FDA's Budget Proposal for FY 2004 (February 3)

January 2003

• FDA Approves First Biologic Therapy for Psoriasis (January 31)
• FDA Issues Guidance for Collection of Race and Ethnicity Data in Clinical Trials for FDA Regulated Products (January 23)
• Patient Safety Study of Asthma Drug Serevent Halted (January 23)
• FDA Proposes New Warning for Over-the-Counter Contraceptive Drugs Containing Nonoxynol-9 (January 16)
• FDA Places Temporary Halt on Gene Therapy Trials Using Retroviral Vectors in Blood Stem Cells (January 14)
• FDA Releases Preliminary Results of Physician Survey on Direct-to-Consumer Rx Drug Advertisements (January 13)
• Phase Two of CBER/CDER Product Consolidation Concludes (January 8)
• FDA Approves Prozac for Pediatric Use to Treat Depression and OCD (January 3)

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