News

*FDA News Press Releases

January 2009

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December 2008

FDA Approves First Nucleic Acid Test to Screen for Additional Types of HIV in Donated Blood and Tissue (December 30)
FDA Approves Drug for Patients with Advanced Prostate Cancer (December 29)
FDA Approves First Imaging Agent to Enhance Scans of Blood Flow (December 24)
FDA Warns Consumers About Tainted Weight Loss Pills (December 22)
FDA Obtains Injunction to Stop Production of Illegally Medicated Animal Feed (December 22)
FDA Approves Gleevec to Prevent Recurrence of Rare Gastrointestinal Cancer(December 19)
Historic Building One Dedicated at FDA’s White Oak Federal Research Center (December 18)
FDA Approves Drug that Boosts Stem Cell Yield for Bone Marrow Transplants (December 18)
FDA Announces New Recommendations on Evaluating Cardiovascular Risk in Drugs Intended to Treat Type 2 Diabetes (December 17)
FDA Requires Warnings about Risk of Suicidal Thoughts and Behavior for Antiepileptic Medications (December 16)
Study Finds Much of Private-Sector Consumer Medication Information Not Consistently Useful (December 16)
FDA Announces Class I Recalls of Two Unapproved Devices (December 15)
FDA Warns Consumers and Retailers of Botulism Risk from Ungutted, Salt-Cured Alewives (Gaspereaux) Fish (December 12)
FDA Requires New Safety Measures for Oral Sodium Phosphate Products to Reduce Risk of Acute Kidney Injury (December 11)
FDA Education Program Wins Award (December 9)
FDA Announces Permanent Injunction Against Wilderness Family Naturals LLC (December 9)
FDA, EPA and USDA Conclude That Accidental Release of Genetically Engineered Cotton Poses No Safety Risk to Humans or Animals (December 3)
FDA Announces Participants of Pilot Program for Third-Party Certification of Imported Aquacultured Shrimp (December 3)
FDA Teams With WebMD For New Online Consumer Health Information (December 3)
FDA Reports Significant Progress in Protecting the Food Supply (December 1)

November 2008

FDA Approves New Drug to Alleviate Moderate to Severe Pain (November 24)
FDA Acts to Avoid Shortage and Strengthen the Safety of Sucraid (November 20)
FDA Approves New Drug to Treat Severe Form of Epilepsy (November 20)
FDA Warns Public of Extortion Scam by FDA Impersonators (November 12)
FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer (November 6)
FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes (November 5)

October 2008

FDA Approves Toviaz, a New Drug to Treat Overactive Bladder (October 31)
HHS/FDA Grants Tentative Approval for 75th Generic Anti-Retroviral Drug as Part of President's Emergency Plan for AIDS Relief (October 29)
FDA Statement on Release of Bisphenol A (BPA) Subcommittee Report (October 28)
FDA Issues Warning Letters to Bayer HealthCare for Illegally Marketing Two Unapproved Drugs (October 28)
FDA Approves Lung Valve to Control Some Air Leaks after Surgery (October 24)
HHS Preparing to Open FDA Offices in China, India, Europe, and Latin America This Year (October 16)
FDA Approves Updated Labeling for Psoriasis Drug Raptiva (October 16)
FDA Creates Web Page with Drug Safety Information for Patients, Health Care Professionals (October 15)
FDA Licenses for Marketing New Therapy for Rare Genetic Disease (October 10)
FDA Approves Rapaflo for the Treatment of Symptoms Due to an Enlarged Prostate Gland (October 10)
FDA Launches Food Defense Awareness Training Kit for Employees in the Food Industry (October 10)
FDA Licenses Drug to Prevent Joint Damage in Children with Hemophilia A (October 10)
FDA Statement Following CHPA's Announcement on Nonprescription Over-the-Counter Cough and Cold Medicines in Children (October 8)
FDA Approves Use of Temporary Pump to Assist Heart's Right Side (October 7)
FDA and PATH Malaria Vaccine Initiative Announce Research Collaboration (October 7)
FDA Detects Melamine Contamination in Flavored Drink (October 6)
FDA Issues Interim Safety and Risk Assessment of Melamine and Melamine-related Compounds in Food (October 3)
HHS Announces New Steps in Anthrax Preparedness (HHS release, October 1)

September 2008

FDA Awards $5.2 Million in Grants to Further Food and Feed Safety (September 30)
FDA Awards up to $2.5 Billion to Modernize Information Technology over Ten Years (September 30)
FDA Analysis Shows Cholesterol Lowering Medications Do Not Increase the Risk of "Lou Gehrig's Disease" (September 29)
FDA Updates Health Information Advisory on Melamine Contamination (September 26)
FDA Warns Companies to Stop Marketing Unapproved Ophthalmic Balanced Salt Solution Drug Products and Topical Drug Products Containing Papain (September 23)
FDA Updates Health Information Advisory on Melamine Contamination (September 23)
FDA Updates Health Information Advisory on Melamine Contamination (September 20)
FDA Proposes Label Requirements for Refused Imported Foods (September 18)
FDA Issues Draft Guidance on Regulating Genetically Engineered Animals (September 18)
FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India (September 16)
FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers (September 12)
FDA Approves Treatment for Rare Neurologic Disease (September 12)
FDA Issues Health Information Advisory on Infant Formula (September 12)
FDA: West Virginia Livestock Owner Sentenced in Criminal and Civil Contempt Case (September 11)
FDA to Post Quarterly Report of Potential Safety Issues (September 5)
FDA Approves DNA Test to Measure Hepatitis B Virus Levels (September 4)
FDA: Manufacturers of TNF-Blocker Drugs Must Highlight Risk of Fungal Infections (September 4)
FDA Approves Software Update that Identifies Potential Defibrillator Lead Fractures (September 4)

August 2008

FDA Clears Test to Help Doctors Manage Heart Transplant Patients (August 27)
FDA Approves First Bone Marrow Stimulator to Treat Immune-Related Low Platelet Counts (August 22)
FDA Warns Consumers Not to Eat Certain Mussel Products from Bantry Bay Seafood (August 15)
FDA Approves First Drug for Treatment of Chorea in Huntington's Disease (August 15)
FDA Warns Consumers About Potential Problems at Two Baltimore Pharmacies (August 8)
FDA Approves 2008-2009 Flu Vaccines (August 5)
FDA Announces Improved Policies Regarding Transparency, Public Disclosure for Advisory Committees (August 4)

July 2008

FDA Clears Test that Helps Identify Type of Cancer in Tumor Sample (July 31)
FDA Extends Consumer Warning on Serrano Peppers from Mexico (July 30)
Federal Agents Seize more than $24 Million in Unapproved New Drugs (July 30)
FDA Approves First Generic Divalproex Sodium to Treat Seizures, Migraine Headaches and Bipolar Disorder (July 29)
FDA Advises Against Consumption of American Lobster (Maine Lobster) Tomalley (July 28)
U.S. Grown Jalapeño and Serrano Peppers Not Connected to Salmonella Saintpaul Outbreak (July 25)
Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product (July 24)
FDA Rule and Companion Guidance Make Early Stage Clinical Drug Development Safe and Efficient (July 18)
FDA Launches Fellowship Program to Develop Pipeline of Scientists, Other Professionals (July 17)
FDA Reaches Settlement with California Hearing Device Maker (July 17)
FDA Revises Process for Responding to Drug Applications (July 9)
FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs (July 8)
FDA Approves New Genetic Test for Patients with Breast Cancer (July 8)
FDA Food Protection Plan Shows Significant Progress (July 2)

June 2008

FDA Approves First Generic Risperidone to Treat Psychiatric Conditions (June 30)
FDA Requests Seizure of Animal Food Products at PETCO Distribution Center (June 19)
United States and China Outline Progress on Agreement on Food and Feed Safety (HHS Release, June 18)
FDA Approves Diaphragm-Pacing Device (June 18)
FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures' (June 17)
FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs (June 16)
FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety (June 12)
Administration Proposes Additional Funding for FDA to Improve Food and Medical Product Safety (HHS release, June 9) [Fact Sheet]
FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes (June 7)
FDA's Chief Scientist Asks Science Board Subcommittee to Review Research on Bisphenol-A (June 6)
FDA Takes Action against Seafood Processing Company, Executives (June 6)
FDA Announces New Labeling Changes for Regranex (June 6)
FDA Announces Limited Return of Heartworm Drug to U.S. Market (June 5)
FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes (June 3)

May 2008

FDA Advises Patients to Switch to HFA-Propelled Albuterol Inhalers Now (May 30)
FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding (May 28)
FDA Requests Recall of Xiadafil VIP Tabs (May 27)
FDA Warns Consumers Against Using Mommy's Bliss Nipple Cream (May 23)
New Efforts to Help Improve Medical Products for Patient Safety and Quality Medical Care (DHHS, May 22)
FDA Approves Entereg to Help Restore Bowel Function Following Surgery (May 20)
FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc. (May 16)
FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled (May 16)
FDA Takes Action against Cream Cheese Companies, Executives (May 15)
Manufacturer Removes Remaining Stocks of Trasylol (May 14)
FDA Approves New Formulation of Coagulation Therapy (May 9)
FDA Approves First Generic Ropinirole (May 9)
FDA Completes Final Analysis of "Total Body Formula" and "Total Body Mega Formula" Products (May 1)

April 2008

Manufacturer of Heart Defibrillator Signs Consent Decree of Permanent Injunction(April 30)
FDA Embarks on Major Hiring Initiative for its Public Health Mission (April 30)
FDA Approves Amitiza for IBS-C (April 29)
Coronary Artery Plaque Imaging Device Cleared by FDA (April 29)
FDA Approves Relistor for Opioid-Induced Constipation (April 24)
FDA Orders Pet Food Maker to Obtain Emergency Operating Permit (April 24)
FDA Proposes Recommendations for Two Animal Drug Funding Programs (April 24)
FDA Strengthens Safeguards for Consumers of Beef (April 23)
FDA Clears Glove Made from New Type of Latex (April 23)
FDA Approves Cimzia to Treat Crohn's Disease (Apr. 22)
FDA Approves First Compact Heart Assist Device (April 21)
Salmonella Illnesses in Multiple States may be Linked to Recently Recalled Cereal (April 12)
FDA Finds Hazardous Levels of Selenium in Samples of "Total Body Formula" and"Total Body Mega Formula" (April 9)
Federal Authorities Seize More Than $100,000 of Unapproved Drugs Marketed as "Natural Supplements" (April 9)
FDA Appoints Dr. Frank M. Torti to Senior Leadership Position (April 9)
Federal Agents Seize Nearly $1.3 Million of Illegal Dietary Supplements (April 4)
FDA Approves New Vaccine to Prevent Gastroenteritis Caused by Rotavirus (April 3)

March 2008

FDA Seeks Civil Penalties from Calif. Device Maker (March 28)
FDA Warns Consumers about "Total Body Formula" and "Total Body Mega Formula" (March 27)
FDA Identifies First Steps in Requirements for Safety Plans for Certain Drugs and Biologics (March 27)
FDA Makes Recommendations on Medical Devices That Treat Blocked Heart Arteries (March 26)
FDA Warns Consumers Not to Use "Blue Steel" and "Hero" Products (March 25)
FDA Warns of Salmonella Risk with Cantaloupes from Agropecuaria Montelibano (March 22)
FDA Approves New Medical Adhesive to Treat Burn Patients (March 19)
FDA Takes Next Step in Establishing Overseas Presence (March 14)
FDA Issues Alert on Tussionex, a Long-Acting Prescription Cough Medicine
Containing Hydrocodone (March 11)
FDA Names Permanent Director for Center for Drug Evaluation and Research (March 10)
FDA Warns Companies Importing and Marketing Drugs Over the Internet that Fraudulently Claim to Prevent and Treat STDs (March 6)

February 2008

FDA Approves Nexium for Use in Children Ages 1-11 Years (Feb. 28)
FDA Approves New Orphan Drug for Treatment of Rare Inflammatory Syndromes (Feb. 27)
FDA Announces Permanent Injunction against Food Companies, Executives (Feb. 22)
FDA Licenses New Hemophilia Treatment (Feb. 21)
FDA Proposes Guidance for Dissemination of Information on Unapproved Uses of Medical Products (Feb. 15)
Baxter's Multiple-dose Vial Heparin Linked to Severe Allergic Reactions (Feb. 11)
FDA Notifies Public of Adverse Reactions Linked to Botox Use (Feb. 8)
New Era Canning Company Expands Nationwide Recall (Feb. 7)
FDA Clears for Market First Decellularized Heart Valve (Feb. 7)
Generic Fosamax Approved (Feb. 6)
FDA Investigation Leads to Several Indictments for Importing Contaminated Ingredients Used in Pet Food (Feb. 6)
FDA Takes Action to Stop the Marketing of Unapproved Injectable Drugs Containing Colchicine (Feb. 6)
FDA Advises Seafood Processors About Ciguatera Fish Poisoning in the Northern Gulf of Mexico Near the Flower Garden Banks National Marine Sanctuary (Feb. 5)
President's FY 2009 Budget Advances Food and Medical Product Safety, and the Safety of FDA-Regulated Imports (Feb. 4)
FDA Issues Public Health Advisory on Chantix (Feb. 1)
FDA Approves Drug-Eluting Stent for Clogged Heart Arteries (Feb. 1)

January 2008

FDA Alerts Health Care Providers to Risk of Suicidal Thoughts and Behavior with Antiepileptic Medications (Jan. 31)
FDA Warns Public of Contaminated Syringes (Jan. 25)
FDA Issues Early Communication about an Ongoing Review of Vytorin (Jan. 25)
FDA Approves New HIV Drug After Priority Review (Jan. 18)
FDA Warns Public of Possible Botulism Risk (Jan. 18)
FDA Approves Update to Label on Birth Control Patch (Jan. 18)
FDA Clears for Marketing Real-Time Test for Respiratory Viruses (Jan. 18)
FDA Releases Recommendations Regarding Use of Over-the-Counter Cough and Cold Products (Jan. 17)
FDA Approves Sealant to Control Bleeding During Surgery (Jan. 16)
FDA Issues Documents on the Safety of Food from Animal Clones (Jan. 15)
FDA Approves Tysabri to Treat Moderate-to-Severe Crohn's Disease (Jan. 14)
FDA Approves New Genetic Test for Breast Cancer Patients (Jan. 14)
FDA Licenses 14 New Blood-Typing Tests (Jan. 11)
FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs (Jan. 9)
FDA Commissioner Names Directors to Food Safety and Veterinary Centers (Jan. 4)
FDA Clears First Test Designed to Detect and Identify 12 Respiratory Viruses from Single Sample (Jan. 3)
FDA Receives New Data on Risks of Anemia Drugs (Jan. 3)
FDA Clears First Quick Test For Drug-Resistant Staph Infections (Jan. 2)

FDA Recalls, Market Withdrawals and Safety Alerts

*Above information straight from FDA website, more information can be found at the above link. These links will take you to the FDA website. This website does not claim any copyright to the information on this page.