Talk Papers and Press Releases

2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997

Note: Documents in PDF format require the Adobe Acrobat Reader®. If you experience problems with PDF documents, please download the latest version of the Reader®


2008

FDA Approves First Nucleic Acid Test to Screen for Additional Types of HIV in Donated Blood and Tissue - 12/30/2008

FDA Licenses for Marketing New Therapy for Rare Genetic Disease - 10/10/2008

FDA Licenses Drug to Prevent Joint Damage in Children with Hemophilia A - 10/10/2008

FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers - 9/12/2008

FDA Approves Treatment for Rare Neurologic Disease - 9/12/2008

FDA Approves 2008-2009 Flu Vaccines - 8/5/2008

FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding - 5/28/2008

FDA Approves New Formulation of Coagulation Therapy: NovoSeven RT Can Be Stored at Room Temperature - 5/9/2008

FDA Approves New Vaccine to Prevent Gastroenteritis Caused by Rotavirus - 4/3/2008

FDA Approves New Medical Adhesive to Treat Burn Patients - 3/19/2008

FDA Licenses New Hemophilia Treatment - 2/21/2008

FDA Approves First Clotting Solution Made Using Recombinant DNA Technology - 1/17/2008

FDA Approves Sealant to Control Bleeding During Surgery - 1/16/2007

FDA Licenses 14 New Blood-Typing Tests: New tests help assure safe transfusions - 1/11/2008

2007

FDA News: FDA Approves Voluven to Treat Serious Blood Volume Loss following Surgery - 12/27/2007

FDA Launches E-mail Alert Subscription Service through Public Web site - 12/3/2007

FDA Approves Change in Storage Conditions for Humate-P - 10/19/2007

FDA Expands Age Range for Use of Bacterial Meningitis Vaccine - 10/18/2007

Additional Influenza Vaccine Approved for Upcoming Influenza Season - 9/28/2007

FDA Approves Nasal Influenza Vaccine for Use in Younger Children - 9/19/2007

FDA Clears for Marketing First Rapid Test to Screen for Bacterial Contamination in Blood Platelets - 9/18/2007

FDA Licenses 15 New Blood Typing Tests - 9/14/2007

FDA Approves Second-Generation Smallpox Vaccine - 9/1/2007

FDA Approves Second West Nile Virus Screening Test for Donated Blood and Organs - 8/28/2007

FDA Approves Human Thrombin for Topical Use in Surgery - 8/28/2007

FDA Statement on Gene Therapy Clinical Trial - 7/26/2007

FDA Releases Human Tissue Task Force Report - 6/12/2007

FDA Finalizes Guidances for Pandemic and Seasonal Influenza Vaccines - 5/31/2007

FDA Approves Expanded Use for Surgical Sealant - 5/15/2007

FDA Approves Product to Treat Common Bleeding Disorder - 4/30/2007

FDA Approves First U.S. Vaccine for Humans Against the Avian Influenza Virus H5N1 - 4/17/2007

FDA Announces Recommendations to Reauthorize Medical Device User Fee Program - 4/16/2007

FDA Licenses First Biologic Product to Prevent Hepatitis B Reinfection in Liver Transplant Patients - 4/6/2007

FDA Approves First Biologic to Treat Rare Clotting Disorder - 3/30/2007

FDA Approves First Fully Automated Test to Screen for West Nile Virus in Blood and Tissue Donors - 3/2/2007

FDA Approves New Product to Treat Von Willebrand Disease - 2/2/2007

FDA Issues Draft Guidance on License Applications for Certain Placental/Umbilical Cord Blood Products - 1/17/2007

FDA Proposes Barring Certain Cattle Material From Medical Products As BSE Safeguard - 1/12/2007


2006

FDA Approves First Test to Screen Blood Donors for Chagas Disease - 12/13/2006

FDA Proposes Rules Overhaul to Expand Availability of Experimental Drugs - 12/13/2005

FDA Approves Test to Help Diagnose Main Virus that Causes AIDS - 10/5/2006

FDA Approves Additional Vaccine for Upcoming Influenza Season - 10/5/2006

FDA Issues Guidance to Industry for Development of Cell-Based Viral Vaccines - 9/28/2006

FDA Issues Guidance to Tissue Establishments - 9/13/2006

FDA Fines American Red Cross $4.2 Million for Failure to Meet Established Blood Safety Laws - 9/8/2006

FDA Forms Task Force on Human Tissue Safety - 8/30/2006

FDA Orders Donor Referral Services and Philip Guyett to Cease Manufacturing Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) and to Retain HCT/Ps - 8/21/2006

FDA Approves Influenza Vaccines To Be Manufactured for Upcoming Flu Season - 8/2/2006

Goldberger Named to Oversee Emerging and Pandemic Threat Preparedness - 7/20/2006

FDA Approves the First Fully Automated Screening and Confirmatory Tests for Hepatitis B Surface Antigen - 7/18/2006

FDA Statement on Blood Product Advisory Committee Meeting on Proposed Clinical Trial for Blood Substitute Product - 7/13/2006

FDA Licenses New Vaccine for Prevention of Cervical Cancer and Other Diseases in Females Caused by Human Papillomavirus - 6/8/2006

FDA Press Release: FDA Licenses New Vaccine to Reduce Older Americans' Risk of Shingles - 5/26/2006

FDA's Accomplishments in 2005 - 3/29/2006

Cooperation on Medicines Regulation Intensified - 3/15/2006

FDA Initiative Helps Expedite Development of Seasonal and Pandemic Flu Vaccines - 3/2/2006

FDA Orders Biomedical Tissue Services, Ltd., to Cease Manufacturing and to Retain Existing Inventories of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) - 2/6/2006

FDA Approves New Vaccine to Prevent Rotavirus Gastroenteritis in Infants - 2/3/2006

FDA Approves New Laboratory Test To Detect Human Infections With Avian Influenza A/H5 Viruses - 2/3/2006

FDA Announces New Prescription Drug Information Format to Improve Patient Safety - 1/18/2006

FDA Approves First Immune Globulin for Subcutaneous Use - 1/10/2006


2005

FDA Approves First Test to Screen for West Nile Virus in Donors of Blood, Organs, Cells and Tissues - 12/1/2005

FDA's Dr. Jesse Goodman Honored by Institute of Medicine - 11/14/2005

FDA Announces the Use of New Electronic Drug Labels to Help Better Inform the Public and Improve Patient Safety - 11/2/2005

FDA Provides Information on Investigation into Human Tissue for Transplantation - 10/26/2005

FDA Announces Rapid Response Team to Combat Pandemic (Avian) Flu - 10/24/2005

FDA Update on Influenza Vaccine Supply - 10/17/2005

Statement by Mike Leavitt Secretary of Health and Human Services International Partnership on Avian and Pandemic Influenza United Nations General Assembly - 9/15/2005

HHS Buys Vaccine and Antivirals in Preparation for a Potential Influenza Pandemic - 9/15/2005

FDA Statement on Chiron Corporation Inspection - 8/31/2005

FDA Approves New Influenza Vaccine for Upcoming Flu Season - 8/31/2005

FDA Approves a New Combination Vaccine to Help Protect Both Adolescents and Adults against Whooping Cough - 6/10/2005

First Combination Vaccine Approved to Help Protect Adolescents Against Whooping Cough - 5/3/2005

Statement from Dr. Jesse Goodman, Director, Center for Biologics Evaluation and Research (CBER), Regarding the MHRA Action Today - 3/2/2005

FDA Approves New Plasma-derived Product to Treat Complications of Smallpox Vaccination - 2/18/2005

NCI and FDA Announce Research and Regulatory Review Fellowship Program Training for Tomorrow: Building a Workforce for the New Age of Molecular Oncology Medicine - HHS - 2/16/2005

FDA Warns Consumers Not to Use Home-Use Diagnostic Kits Marketed by Globus Media - 2/7/2005


2004

HHS Purchases 1.2 Million Doses of Flu Vaccine - 12/7/2004

HHS News Release - More Than 17 Million Flu Vaccine Doses Shipped In Six Weeks - 11/24/2004

FDA Improves the Safety of Human Cells and Tissues by Finalizing New Rules for "Good Tissue Practice" - 11/18/2004

FDA Names Dr. Edward Otto as New Director of the Office of Cellular, Tissue and Gene Therapies - 10/28/2004

FDA Team Completes Inspection of Chiron's Liverpool Flu Vaccine Plant - 10/15/2004

HHS Secretary Urges States to Aggressively Prosecute Flu Vaccine Price Gouging - 10/14/2004

FDA and U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) Working Cooperatively to Address Flu Vaccine Quality at Chiron's U.K. Facility - 10/13/2004

HHS Statement on Chiron Flu Vaccine - 10/5/2004

FDA Issues Final Report on Its "21st Century" Initiative on the Regulation of Pharmaceutical Manufacturing - 9/29/2004

FDA Finalizes New Rule on Donor Eligibility for Human Tissues and Cells - 5/20/2004

CBER Issues Annual Report for Fiscal Year 2003 And Outlines New Directions for 2004 - 4/30/2004

Notice to Readers: Manufacturer's Recall of Human Rabies Vaccine - MMWR - 4/2/2004

NIH and FDA Launch New Human Gene Transfer Research Data System - 3/26/2004

FDA Approves First Oral Fluid Based Rapid HIV Test Kit - 3/26/2004

FDA Rule Requires Bar Codes on Drugs and Blood to Help Reduce Errors - 2/25/2004

HHS Takes New Steps to Protect Consumers from Counterfeit Drug Threats - 2/18/2004

FDA and SEC Work to Enhance Public's Protection from False and Misleading Statements - 2/5/2004

FDA Statement - Broader Requirements for Tissue Bank Registration and Listing Become Effective Today - 1/21/2004

FDA Sees Rebound in Approval of Innovative Drugs in 2003 - New Innovation Initiative Anticipated to Speed Approvals in Years Ahead - 1/15/2004

FDA Advances Consumer Health and Safety in 2003 - 1/13/2004


2003

FDA Issues Final Rule and Final Order Regarding Safety and Efficacy of Certain Licensed Biological Products Including Anthrax Vaccine - 12/30/2003

FDA Investigating Reports of Unlicensed Influenza Vaccine - 12/23/2003

FDA Issues Guidance on Pharmacogenomics Data: Guidance intended to ensure that evolving policies are based on the best science; provide public confidence in this new field - 11/3/2003

FDA Anti-Counterfeiting Task Force Interim Report Focuses on High-Tech Weapons and Other Promising New Counter Measures

FDA Announces Device User Fees for FY 2004 - 7/31/2003

FDA Proposes New Rules to Revise Blood Storage and Container Labeling Requirements - 7/29/2003

New Recombinant Antihemophilic Factor Licensed - 7/25/2003

FDA Announces Initiative to Heighten Battle Against Counterfeit Drugs - 7/16/2003

First Nasal Mist Flu Vaccine Approved - 6/17/2003

Federal Register Report and FDA Web Site on Postmarketing Studies - 5/29/2003

FDA Statement on BSE Cow in Alberta, Canada - 5/20/2003

FDA Approves First Treatment for Genetic Metabolic Disorder Including Hurler Disorder - 4/30/2003

FDA Approves First Treatment for Fabry Disease - 4/24/2003

FDA Issues Guidance on Severe Acute Respiratory Syndrome to Further Safeguard the Blood Supply - 4/17/2003

FDA Proposes Bar Codes for Drugs, Blood; New Adverse Reaction Reporting - 3/13/2003

FDA Advisory Committee Discusses Steps for Potentially Continuing Certain Gene Therapy Trials That Were Recently Placed on Hold - 2/28/2003

Update on FDA's Continuing Investigation of Particulate Matter in Blood Shows Normal Blood Components and No Evidence for an Increase in Adverse Events - 2/27/2003

FDA Completes First Steps of its Broad Initiative to Improve Regulation of Pharmaceutical Manufacturing - 2/20/2003

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 - 2/7/2003

FDA Issues Guidance for Collection of Race and Ethnicity Data in Clinical Trials for FDA Regulated Products - 1/23/2003

FDA Places Temporary Halt On Gene Therapy Trials Using Retroviral Vectors In Blood Stem Cells - 1/14/2003


2002

FDA Announces Smallpox Vaccine Guidance for Blood Industry - 12/30/2002

Jesse Goodman, M.D., MPH, Named Director of CBER; Kathryn Zoon, Ph.D., Moves to NIH - 12/17/2002

New Pediatric Combination Vaccine Approved - 12/16/2002

FDA Statement on Blood Industry's Voluntary Market Withdrawal of Certain Frozen Blood Products to Reduce Risk of West Nile Virus Transmission from Transfusion - 12/12/2002

FDA Approves New Rapid HIV Test Kit - 11/7/2002

FDA Issues Final Guidance to Industry on West Nile Virus - 10/25/2002

FDA Unveils New Initiative To Enhance Pharmaceutical Good Manufacturing Practices - 8/21/2002

FDA Issues Order to Recall and To Prevent Further Use of Human Tissue Processed at Cryolife, Inc. - 8/14/2002

HHS May Acquire More Than 75 Million Doses of Smallpox Vaccine - 3/29/2002

FDA Approves First Nucleic Acid Test (NAT) System to Screen Whole Blood Donors for Infections with Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) - 2/28/2002

Protein Patterns May Identify Ovarian Cancer - 2/7/2002

FDA Approves License Supplements for Anthrax Vaccine - 1/31/2002


2001

FDA Asks Federal Court to Hold American Red Cross in Contempt of 1993 Consent Decree and Impose Prospective Fines for Violations - 12/13/2001

FDA Statement - Confirmatory anthrax testing at all its buildings show buildings are negative for anthrax - 11/5/2001

Questions and Answers About Anthrax Prevention and Treatment - HHS News - 10/10/2001

FDA Approves First Nucleic Acid Test (NAT) Systems to Screen Plasma for Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) - 9/21/2001

FDA Issues Draft Guidance to Further Reduce the Possible Risk of Transmission of Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products - 8/27/2001

New Combination Vaccine Approved for Protection Against Two Hepatitis Viruses - 5/14/2001

Newly Formulated DTaP (Diphtheria, Tetanus, and Pertussis) Vaccine Approved with Only Trace Amounts of Thimerosal - 3/7/2001


2000

FDA Issues Safety Alert on Unapproved Goat Serum Treatment for HIV/AIDS - 12/22/2000

Physician Labeling Proposal - HHS News - 12/21/2000

Wyeth-Ayerst Laboratories Signs Consent Decree with FDA - 10/3/2000

Guidance for Adverse Reactions Labeling - 6/23/2000

FDA Alerts Health Professionals and Consumers to Nationwide Recall of Clinipad Antiseptic Sterile Products - HHS NEWS - 3/10/2000

FDA's Law Enforcement in FY 1999 - 3/8/2000

New Initiatives to Protect Participants in Gene Therapy Trials - HHS NEWS - 3/7/2000

First Pneumococcal Vaccine Approved for Infants and Toddlers - Pnuemococcal 7-valent Conjugate Vaccine (Prevnar), Lederle Laboratories Division American Cyanamid Company - 2/17/2000

FDA's Report On New Health Care Products Approved in 1999 - 1/18/2000


1999

Abbott Labs Signs Consent Decree With FDA; Agrees to Correct Manufacturing Deficiencies - HHS News - 11/2/1999

New Precautionary Measures to Reduce the Theoretical Risk of New Variant CJD From Blood Products - 8/17/1999

FDA Approves First Home Test for Hepatitis C Virus - 4/29/1999

First Biologics Approved for Clotting Disorder - Antihemophilic Factor/von Willebrand Factor Complex (Human)(Humate-P), Centeon Pharma G.M.B.H. - 4/1/1999

FDA Licenses Improved Supplemental Test for Hepatitis C - 2/11/1999

Recall of One Lot of Tripedia Because of Subpotent Diphtheria Component - 1/29/1999

FDA's Report on New Health Care Products Approved in 1998 - 1/15/1999


1998

FDA Approves First Lyme Disease Vaccine - HHS News - Lyme Disease Vaccine (Recombinant OspA) (LYMErix) - 12/21/1998

New Oral Rotavirus Vaccine Helps Prevent Severe Childhood Diarrhea and Vomiting - HHS News - Rotavirus Vaccine, Live, Oral, Tetravalent (Rotashield), Wyeth Laboratories, Inc. - 8/31/1998

FDA Proposes Rules for Dissemination of Information on Off-Label Uses - HHS News - 6/5/1998

FDA Clears New Hepatitis C Treatment for Marketing - 6/3/1998

FDA Approves Alternative to Fresh Frozen Plasma - Pooled Plasma, Solvent Detergent Treated (VIPLAS/SD, PLAS+SD), V.I. Technologies, Inc. - 5/6/1998

New Fibrin Sealant Approved to Help Control Bleeding in Surgery - Fibrin Sealant (TISSEEL VH Kit), Osterreichisches Institut Fur Haemoderivate Ges.m.b.H. - 5/1/1998

Alpha Therapeutic Consent Decree - 1/27/1998

FDA Biologics Approvals in 1997 - 1/16/1998


1997

The FDA Modernization Act of 1997 - 11/21/1997

FDA Warns Consumers About Two Unapproved Home-Use Test Kits - 9/26/1997

FDA Grants Accelerated Approval to Help Repair Damaged Knee Cartilage - Autologous Cultured Chondrocytes (Carticel SM Service), Genzyme Tissue Repair - 8/22/1997

FDA Seeks Public Comment on Informed Consent Rules in Combat Situations - 7/29/1997

Recombinant Human Factor VIII Recalled Because of Possible Contamination With Mold - 7/14/1997

Safety of Gelatin and Gelatin By-Products Reviewed - 4/24/1997

Reinventing the Regulation of Human Tissue - 2/28/1997

New Recombinant Product for Hemophilia B - Coagulation Factor IX (Recombinant) (Benefix), Genetics Institute, Inc. - 2/11/1997

 
Updated: December 31, 2008