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International Regulatory Affairs Focus: New H5N1 vaccine
New-style bird flu vaccine shows promise.Thu Jun 12, 2008 2:38am BST; Posted 13 June, 2008
WASHINGTON, June 11 (Reuters) - A new-style bird flu vaccine made using monkey cells instead of chicken eggs appears to be safe and effective, corporate researchers reported on Wednesday.

The vaccine against H5N1 avian influenza, made by Baxter International (BAX.N: Quote, Profile, Research), is the first bird flu vaccine to be made using cells in a lab dish instead of chicken eggs. This is important because the right type of chicken eggs are difficult to obtain -- and because H5N1 kills chickens rapidly.

International Regulatory Affairs Focus- Bird flu drugs
28 August, 2007 Roche and WHO reinforce Tamiflu as primary H5N1 treatment. Source: News-Medical.Net; Pharmaceutical News; Published: Sunday, 26-Aug-2007. Experts believe that a human influenza pandemic is imminent and could be triggered by the highly pathogenic H5N1 strain, which to date has infected 321 humans causing 194 deaths worldwide (as of Aug 16 2007).

H5N1 Bird flu Vaccine Update- Bird flu Regulatory Focus

Avian influenza H5N1 Vaccines: Bird flu Regulatory News Alert
19-Jun-2007. Global stockpile of H5N1 vaccines .
Source: NewsMedical.Net; Disease/Infection News. 23 June 2007: Date posted on International Regulatory Affairs Updates website.

The World Health Organization (WHO) has announced that it is working with vaccine manufacturers to move ahead on plans to create a global stockpile of vaccine for the H5N1 avian influenza virus.

Avian influenza H5N1 in Ghana
Second Farm in Ghana Harbors the Lethal Avian influenza strain H5N1 .

By Solomon K. Sackitey

Date published: 09 May 2007

Date posted on the web: 10 May 2007

Summary
In this report, a second farm has been recorded as Ghana’s bird flu incidence since the first one was reported barely a week ago. The H5N1 cases in Ghana do not involve any human infections. Efforts made by the Ghana government to contain the situation have been stated. In addition, future plans have been outlined. A cross-functional Avian Influenza Working Group(AIWG)preparedness plan involving National and International experts which could serve as a model system for the rest of Africa is also highlighted.

Introduction
Nearly a week after the Ghana government announced the country’s first bird flu case on a small poultry farm at the port city of Tema, another incidence has occurred in the same Tema municipality. If WHO tests prove to be affirmative, the list of African countries with H5N1 cases will increase to eight. The other countries are Djibouti, Egypt, Cameroon, Burkina Faso, Sudan, Cote d’Ivoire (Ivory Coast), Niger and Nigeria. Egypt, Djibuoti and Nigeria are the only three African countries with recorded human cases. While thousands of birds have been culled in Africa, only fifteen people have so far died on the continent from the H5N1 infection. There are no clinical signs of human infection in the bird flu cases in Ghana.

According to Dr. Harry Opata, World Health Organization (WHO) National Program Officer-Disease Prevention and Control, “a national preparedness plan has been put in place since Nov 2005. It has addressed communication to the public, surveillance of bird and human flu, preventive and control measures and finally, strengthening the health system to manage human infections. The government and other agencies like the African Development Bank and the USAID have provided funding for implementation of these actions”. A national Taskforce has been meeting regularly to review how the situation is evolving, he added.

In a statement from Dr. Opata, on 8th May 2007, the National Taskforce on Avian Influenza was informed by the Veterinary Services that a second farm, located within 8 km radius from the initially reported outbreak had also tested positive for H5N1. This is a larger farm; 11,698 fowls had been culled and 9,840 eggs destroyed in response.

Dr. Opata added, “so far, 68 samples have been taken from 29 farms in active surveillance by the Veterinary Services of the Ministry of Food and Agriculture. These farms are all located within 10 km off the farm that was first diagnosed as having been infected with H5N1 virus. Further active surveillance activities are being carried out in the whole of the Tema Municipal Area”.

The Tema Municipal Health Directorate has kept the two farm-communities under surveillance since the outbreaks were declared. In the first farm, the total of 25 community members were line-listed and visited alternate daily and checked for signs of flu-like illness. 13 of these persons had been working directly on the farm or took part regularly / most recently in handling poultry. 9 days after the culling of the fowls none of these persons under surveillance has developed signs of flu-like illness. Similar surveillance activities have been initiated at the second farm, where the community numbered 36.

Actions Taken
In a second statement by Dr Opata, under the auspices of the National Disaster Management Organization (NDMO) of the Ministry of Interior, the National Taskforce on Avian Influenza has held three meetings since the onset of the outbreak and has served as the major source of advice to the Ministries of Agriculture, of Health and of Information.

Technical support has been provided to the Taskforce by USAID, WHO and other partners. A communications’ sub-group has been charged to respond to concerns arising from the current outbreak situation from the general public and such bodies as the Poultry Farmers Association.

The Human Health Sub-group of the Taskforce has held two meetings and issues that are being addressed are:

• the rapid response team should continue to support the various district health teams in the response activities
• sentinel sites for surveillance of influenza be set up in the Greater Accra Region to monitor current situation and for early identification of changing trends in human influenza
• a rapid assessment of selected health facilities be carried our and support provided to improve ability to handle human influenza. These facilities include the Military and Police Hospitals which have provided support to the general public in emergencies.
• pre-positioning of surveillance equipment (PPEs and Lab Sample collection tool) and Tamiflu in strategic institutions and with the 10 Regional Pharmacists

Actions to be carried out
Dr. Opata’s statement also elaborated on actions to be carried out as follows:
•The communications sub-group to come out by the end of current week with modalities to expand the capacity of the information control post and relocate it to the premises of the National Disaster Management Organization. Information had been handled by the Veterinary Services and the Disease Surveillance Department hot-line arrangements until the onset of the outbreak.

•Health Sub-group to advise Taskforce on how to keep surveillance of laboratory staff and other staff that regularly handle H5N1 infected materials

•Veterinary services to collaborate with NADMO to support the Tema Municipal Administration in enforcing sanitary regulations in the Municipality and surrounding areas.

•Veterinary Services to collect samples in parallel and send one to the NMIMR while the other is sent through the veterinary laboratory system to Podova – Italy. Further, all samples that have tested negative at the veterinary laboratory should be retested at the NMIMR with the real-time RT-PCR

•Department of Wildlife of the Ministry of Forestry and Mineral Resources to start ringing of migratory birds, especially at the Sakumono Ramsar site that is adjacent to Tema

•Veterinary services advocate of early compensation of affected farmers so as to allay fears of the public and improve farmers support to surveillance and containment activities

Ghana’s first case of bird flu
On 02 May 2007, poultry had tested positive for H5N1 at the Noguchi Memorial Institute for Medical Research (NMIMR) in Accra. The positive test had been corroborated within 36 hours by The U.S. Naval Medical Research Unit No.3 (NAMRU-3) – Cairo, Egypt, where the samples had been forwarded through the NMIMR. NAMRU is charged with research and surveillance functionalities for the US military deployed to Africa, the Middle East and Southwest Asia. Their mission also includes the evaluation of vaccines, therapeutic agents, diagnostic assays, and vector control measures.

Following the first outbreak, emergency steps to contain the outbreak were quickly outlined to the public and other governmental agencies. The Ministry of Food and Agriculture (MOFA) Minister, Mr. Ernest Debrah had ordered the indefinite suspension of import/export activities of birds and had instructed the culling of nearly 2000 birds on the farm

Preparedness strategies put in place in Ghana since 2005
A multifaceted Avian Influenza Working Group (AIWG) whose mission was to devise a risk assessment and Preparedness Plan, was drawn with members from the Ghana Health Service-Ministry of Health, Veterinary Services-Ministry of Food and Agriculture, Wildlife Division-Ministry of Lands, Forestry and Mines, World Health Organization, Food and Agriculture Organization of the United Nations (FAO), United States Agency for International Development (USAID), Quality Health Partners, Noguchi Memorial Institute for Medical Research (NMIMR), University of Ghana, Legon and the National Disaster Management Organization (NADMO) of the Ministry of the Interior. In addition, the AIWG developed a document which included cost estimates for resource mobilization and implementation of the plan in both the human and animal health perspectives.

The five-category plan centered around

A.Planning and coordination: to devise strategies for preparedness and response policy actions, among others.

B.Surveillance, situation monitoring and assessment: involves multiple agencies to develop surveillance, monitoring and risk assessments and management in humans, wildlife and in animals.

C.Prevention and containment: the task of systems implementation and containment measures were assigned to the Ministry of Health whilst the Noguchi Memorial Institute for Medical Research would be responsible for the design and development of quick and sensitive methodologies for the isolation and detection of the virus. Prevention and containment of a possible pandemic in animals was a dual role to be undertaken by MOFA and the Veterinary Services and Wildlife Department.

D.Health System Response: involves all public health stakeholders in the private and public sectors.

E.Communications: When the audience is confused or unclear about what is going on with the bird flu, the general public is apt to making uncomfortable decisions and taking misguided policy actions. With this in mind, the plan has provided measures to aid in spreading the word about this threat in an expeditious manner. The Health Promotion Unit of the Ghana Health Service was assigned the role to coordinate communication actions of the lead technical Ministries, their Public Relations Units and other agencies.

While several African governments and public health groups in Africa and abroad have provided series of precautionary measures in an effort to prevent a pandemic, the preparedness and implementation strategies in the Ghana plan could be taken in concert with other plans for an effective mobilization of a continental policy action.

Worldwide Bird flu cases since 2003
It started like a little drop of water in Southeast Asia in 2003. Then steadily and slowly, the dreaded Avian influenza virus strain popularly known as bird flu appears to be gaining momentum to form a mighty global ocean with no boundaries.

As of 11 April, 2007, two hundred and ninety-one humans have been infected in Asia, Europe and Africa out of which 172 people have died, 14 of the dead were in Africa.

Several African governments and public health groups in Africa and abroad have provided series of precautionary measures in an effort to prevent a pandemic. When the audience is confused or unclear about what is going on with the bird flu, the general public is apt to making uncomfortable decisions and taking misguided policy actions. With this in mind, the following resources are provided to aid in spreading the word about this threat in an expeditious manner:

Additional Resources:

(1) Questions and answers on pandemic influenza vaccine

(2) Avian influenza H5N1 Regulatory Updates and Vaccines Initiatives
(3) Avian influenza H5N1 (bird flu) human cases in three African Countries

(4) Avian influenza control and eradication
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Solomon, a Datelinehealth-Africa (DLHA) News Service Avian influenza (H5N1) Alert sub-editor is DLHA award winning United Nations Online Volunteer of the Year 2006 . The research work of Solomon and his colleagues includes publications on HIV/AIDS DNA Vaccines, E. coli O157:H7 detection and Maize Transposable Elements. He has authored series of articles on the bird flu through which he contributed to developing and managing knowledge by stimulating the formulation of action plans, guiding policy processes and supporting research on Avian influenza for African countries. (UNV news release December 2006)
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International Regulatory Affairs Focus- Bird flu human cases in Africa

International Regulatory Affairs Focus- Influenza Genome Sequencing Project

International Regulatory Affairs Focus- Avian flu (H5N1) DNA Vaccine

International Regulatory Affairs Focus- Pandemic flu mortality

International Regulatory Affairs Focus- Avian influenza detection

International Regulatory Affairs Focus- Avian flu pandemic vaccine
Avian influenza Regulatory Alert- 17 December 2006. GlaxoSmithKline reaches EU regulatory milestone in its flu pandemic vaccine development programme.

GlaxoSmithKline; Issued – Friday 15 December 2006, London, UK & Rixensart, Belgium - GlaxoSmithKline Biologicals today announced that Daronrix®, its first generation alum-adjuvanted inactivated whole virus candidate flu vaccine* for use once a pandemic has officially been declared by the WHO/EU, has received a positive opinion from Europe’s Committee for Medicinal Products for Human Use (CHMP).

International Regulatory Affairs Focus- Rapid Diagnostic Tests for Avian Influenza

International Regulatory Affairs Focus- New Avian flu drug
Avian influenza Regulatory alert- 30 November 2006. New bird flu drug will provide new line of defence.

Pharmaceutical News/News-Medical.Net; Published: Tuesday, 28-Nov-2006. Date posted on International Regulatory Affairs Updates website: 30 November 2006. Peramivir could totally transform global preparations for an influenza pandemic as it has been seen in studies to be more powerful and easier to deliver than either Tamiflu or Relenza, the two existing drugs for H5N1 flu.

International Regulatory Affairs Focus- Regulatory File for H5N1 Vaccine
Avian influenza Regulatory alert- 30 November 2006. Novartis submits first regulatory file for H5N1 adjuvanted influenza vaccine with European regulators for pre-pandemic avian influenza prevention.

Pre-pandemic MF59-adjuvanted H5N1 vaccines could protect against a broader range of viruses in case of a avian flu pandemic situation.

Regulatory agencies evaluating the use of adjuvants such as MF59 for lessening the severity of a pandemic.


Novartis Vaccines; Latest News Published: 28-Nov-2006. Date posted on International Regulatory Affairs Updates website: 30 November 2006. . Basel, November 28, 2006 - Novartis announced today that the European Medicines Agency (EMEA) has accepted for review the company’s application for an MF59-adjuvanted pre-pandemic H5N1 influenza vaccine.

International Regulatory Affairs Focus- Bird flu Pandemic
Avian influenza Regulatory Alert- 16 November 2006. Scientists Identify Genetic Changes That Could Lead to Bird Flu Pandemic;
ConsumerAffairs.com. November 16, 2006 The new work, reported in the Nov. 16 issue of the journal Nature, illustrates the genetic changes required for the H5N1 avian influenza virus to adapt to easily recognize the receptors that are the gateway to human cells.

International Regulatory Affairs Focus- Bird flu Vaccine Potency
Avian influenza Regulatory alert- 16 November 2006. HHS says stockpiled H5N1 vaccine is losing potency; Robert Roos, News Editor ; Nov 16, 2006 (CIDRAP News) – Federal health officials say much of the H5N1 avian influenza vaccine bought for the US stockpile is losing potency, with the result that the number of people who could be vaccinated has dropped by about 1 million since July.

International Regulatory Affairs Focus- Avian flu Drugs
Avian influenza Regulatory alert- 14 November 2006. FDA urges new Tamiflu warning . United Press International. 13 November 2006.
WASHINGTON, Nov. 13 (UPI) -- The U.S. Food and Drug Administration Monday urged adding a new warning for the flu drug Tamiflu amid reports of psychiatric problems in patients who take it.

International Regulatory Affairs Focus- Avian influenza Detection

International Regulatory Affairs Focus-Avian flu vaccines
Avian influenza Regulatory alert- 31 October 2006. CDC TO EVALUATE NOVAVAX PANDEMIC INFLUENZA VACCINE CANDIDATE. First Opportunity To Test Novel Vaccine Against Live Virus

Novavax Press Release/ PRNewswire MALVERN, Pa., Oct. 31 /PRNewswire-FirstCall/ -- (Nasdaq: NVAX) - Novavax, Inc. said today the U.S. Centers for Disease Control and Prevention (CDC) has agreed to evaluate the companys H5N1 pandemic influenza vaccine candidate including pre-clinical testing of the vaccine against live bird flu virus.

International Regulatory Affairs Focus-Avian influenza H5N1 Vaccine Trials

International Regulatory Affairs Updates-Bird flu vaccine trials

International Regulatory Affairs Updates-Avian influenza vaccine trials
Avian influenza Regulatory alert- 12 October 2006. Avian influenza (H5N1) Vaccine Trials. NIAID May 2006 QUESTIONS AND ANSWERS H5N1 Avian Flu Vaccine Trials

International Regulatory Affairs Focus- Bird flu Drugs
Avian influenza Regulatory alert- 30 September 2006. BioCryst reports positive safety peramivir data Fri Sep 29, 2006 6:48am ET . NEW YORK, Sept 29 (Reuters) - BioCryst Pharmaceuticals Inc. (BCRX.O: Quote, Profile, Research) on Friday reported early trial results for its influenza treatment, peramivir, showing it can be safely given at high dose levels.
The company has said peramivir has shown a broad-spectrum activity against multiple strains of flu, including the H5N1 virus that causes bird flu, in preclinical trials. U.S. regulators In January granted "fast-track status" for peramivir, potentially allowing for a speedy review of the treatment.

International Regulatory Affairs Focus- Bird flu Vaccine

International Regulatory Affairs Focus- H5N1 Drug

International Regulatory Affairs Focus- Avian flu Alert

International Regulatory Affairs Focus- Avian flu Medication
Avian influenza Regulatory alert- 19 September 2006. Roche hikes US Tamiflu production capacity. By Gregory Roumeliotis. 18/09/2006- In-Pharma Technologist. Roche has boosted annual manufacturing capacity for Tamiflu (oseltamivir phosphate) to 80m treatment courses, as demand for the flu drug shows no sign of abating.

International Regulatory Affairs Updates-Avian influenza Regulatory focus
Avian influenza Regulatory alert- 15 September 2006. Live H5N1 Avian Flu Virus Vaccines Show Protection In Animal Studies
.
Medical News Today. Article Date: 13 Sep 2006 - 0:00am (PDT) When tested in mice and ferrets, experimental vaccines based on live, weakened versions of different strains of the H5N1 avian influenza virus were well-tolerated and protected the animals from a deadly infection with naturally occurring H5N1 flu viruses.

International Regulatory Affairs Focus: New Avian flu strain vaccine

International Regulatory Affairs Focus: Avian influenza virus samples
Global sharing of avian influenza virus samples Disease/Infection News ; Published: Wednesday, 2-Aug-2006. Date Posted: 08 August 2006

OFFLU, the OIE/FAO joint network of expertise on avian influenza, will systematically make avian influenza virus sequences accessible to the entire scientific community.

International Regulatory Affairs Focus: Avian influenza vaccine
Defra invites tenders for avian influenza vaccine; Disease/Infection News ; Published: Thursday, 13-Jul-2006 Date Posted: 08 August 2006

Tenders to supply a further 10 million doses of avian influenza vaccine for potential use in poultry and other captive birds have been welcomed by Defra

International Regulatory Affairs Focus: Bird flu DNA Vaccine

International Regulatory Affairs Updates-Avian influenza Regulatory focus

International Regulatory Affairs Updates-Avian influenza Regulatory focus

International Regulatory Affairs Updates-Avian influenza Regulatory focus
Avian influenza Regulatory alert- 02 May 2006. Vical bird flu vaccine stops H5N1 in animals. Tue May 2, 2006 6:29 PM BST . By Maggie Fox, Health and Science Correspondent WASHINGTON (Reuters) - An experimental bird flu vaccine may show the potential to protect not only against the feared H5N1 virus but perhaps other strains of influenza as well, researchers said on Tuesday.

International Regulatory Affairs Updates-Avian influenza Regulatory focus
Avian influenza Regulatory alert- 22 April 2006. WHO will be hosting 3 meetings to be held in Geneva in the next two months.

WHO/OIE/FAO consultation on the technical feasibility of human vaccine production in veterinary vaccine production facilities during a pandemic, 27 April 2006.

WHO consultation for the development of a global action plan for increasing pandemic vaccine supply, 2-3 May 2006.

WHO meeting on clinical trials of influenza pandemic vaccines, 4-5 May 2006


WHO Consultations on Influenza Vaccines

International Regulatory Affairs Updates-Avian influenza Regulatory focus

International Regulatory Affairs Updates-Avian influenza Regulatory focus

International Regulatory Affairs Updates- Regulatory focus

International Regulatory Affairs Updates-Regulatory focus

International Regulatory Affairs Updates-Regulatory focus

International Regulatory Affairs Updates-Avian influenza Regulatory focus

International Regulatory Affairs Updates-Avian influenza Regulatory focus
Avian influenza Regulatory Alert- 14 February 2006; Recombinomics Inc. Predicts Important Genetic Change in the H5N1 (Avian Flu) Virus PITTSBURGH, Feb. 14 /PRNewswire/ Recombinomics Inc. issued an avian influenza prediction and warning on October 22, 2005 of a likely genetic alteration in the H5N1 hemagglutinin gene that would lead to more efficient transmission of H5N1 to humans.

International Regulatory Affairs Updates-Avian influenza Regulatory focus
Avian influenza Regulatory Alert- 14 February 2006; Skystar Bio-Pharmaceutical Developing Avian Influenza (H5N1) Vaccine for Humans and Animals XI’AN, CHINA -- (MARKET WIRE) -- 02/14/2006 Skystar Bio-Pharmaceutical (OTC BB: CGPN), a leading Bio-Pharmaceutical Company in China, announced that they are developing the highly efficient Avian Influenza Inactivated Vaccine for poultry, birds and humans

International Regulatory Affairs Updates-Avian influenza Regulatory focus
Avian influenza Regulatory Alert-14 February 2006. Penn State Fayette professor says avian flu vaccine advancements vital in war against pandemic By Tim Sweet, For the Herald-Standard; 02/13/2006 Dr. Joshua Marvit, a professor at Penn State Fayette, the Eberly Campus, believes that recent advancements in avian flu vaccination at the University of Pittsburgh could prove vital in staving off a future pandemic.

International Regulatory Affairs Updates-Avian influenza Regulatory focus
Avian influenza Regulatory Alert- 14 February 2006; Experts question generic bird flu vaccine LONDON, Feb. 14 (UPI) 02/14/2006 A bird flu vaccine ordered by the British government in an effort to prevent a pandemic may be ineffective, The Times of London reported Tuesday.

International Regulatory Affairs Updates-Avian influenza Regulatory focus
Avian influenza Regulatory Alert-14 February 2006; Analysis: Trials to spur vaccine immunity By TODD ZWILLICH ; WASHINGTON, Feb. 13 (UPI) Vaccine makers are likely to see immunity from lawsuits by the time they move new avian flu countermeasures into clinical trials, Health and Human Services Secretary Michael Leavitt said Monday.

International Regulatory Affairs Updates-Avian influenza Regulatory focus
Avian influenza Regulatory Alert-14 February 2006. WHO publishes draft proposals for rapid response and containment of high-risk influenza outbreak Continuity Central (press release; 02/14/2006 The World Health Organization has published a new document: “WHO pandemic influenza draft protocol for rapid response and containment.” This outlines current thinking on how the organization will coordinate response to the occurrence of a high-risk influenza outbreak.

International Regulatory Affairs Updates-Avian influenza Regulatory focus
Avian influenza Regulatory Alert- 11 February 2006. Researchers Try to Boost Supply of Flu Vaccine By David BrownWashington Post Staff Writer; Saturday, February 11, 2006; Medical researchers bracing for a global influenza epidemic are in frantic search of a way to perform a loaves-and-fishes miracle with the world's skimpy annual production of flu vaccine.

International Regulatory Affairs Updates-Avian influenza Regulatory focus

International Regulatory Affairs Updates-Avian influenza Regulatory focus

International Regulatory Affairs Updates-Avian influenza Regulatory focus

International Regulatory Affairs Updates-Avian influenza Regulatory focus
Avian influenza Regulatory Alert- 28 January 2006. New bird flu shot took just a month to make, protects chickens Fri Jan 27, 2006 8:46 AM GMT By Maggie Fox, Health and Science Correspondent WASHINGTON (Reuters) - A new bird flu vaccine made using cleaner technology took just a month to make and completely protected chickens from the deadly H5N1 virus, U.S. researchers reported on Thursday.

International Regulatory Affairs Updates-Avian influenza Regulatory focus

International Regulatory Affairs Updates-Avian influenza Regulatory focus

International Regulatory Affairs Updates-Avian influenza Regulatory focus

International Regulatory Affairs Updates-Avian influenza Regulatory focus

International Regulatory Affairs Updates-Avian influenza Regulatory focus
Avian influenza Regulatory alert- 25 January 2006; U.S. flu vaccine manufacturers plan to ramp up production Expecting rising demand for flu shots, pharmaceutical companies are gearing up to produce as many as 120 million doses of vaccine for next flu season.

International Regulatory Affairs Updates-Avian influenza Regulatory focus

International Regulatory Affairs Updates-Avian influenza Regulatory focus

International Regulatory Affairs Updates-Avian influenza Regulatory focus

International Regulatory Affairs Updates-Avian influenza Regulatory focus
Avian influenza Regulatory alert- 24 January 2006 FDA Statement; 20 January 2006; FDA Statement on Fraudulent, Unapproved Influenza-Related Products

International Regulatory Affairs Updates-Avian influenza Regulatory focus
Avian influenza Regulatory alert- 24 January 2006 OIE Avian influenza: Vaccines and Diagnostic methods

International Regulatory Affairs Updates-Avian influenza Regulatory focus
Avian influenza Regulatory alert- 24 January 2006 Reuters; Fri Jan 20, 2006 7:56 AM ET; By Tom Armitage. Tamiflu works against deadly bird flu strain: Roche

International Regulatory Affairs Updates-Avian influenza Regulatory focus
Avian influenza Regulatory alert- 24 January 2006 Reuters; Thu Jan 19, 2006 12:40 AM GMT By Patricia Reaney Newer flu drugs more effective than old: study

International Regulatory Affairs Updates-Avian influenza Regulatory focus

International Regulatory Affairs Updates-Avian influenza Regulatory focus
Avian influenza Regulatory alert- 24 January 2006 ChannelNews; 13 January 2006; By Serene Chua, TODAYSingapore's avian flu test kit endorsed by WHO. AS the world prepares for an avian flu outbreak, a test kit produced by home-grown medical diagnostic company, Veredus Laboratories, has been given an endorsement by the World Health Organization (WHO).

International Regulatory Affairs Updates-Avian influenza Regulatory focus
Avian influenza Regulatory alert- 24 January 2006 ; European Medicines Agency Summary Report : Review on influenza antiviral medicinal products for
potential use during pandemic

International Regulatory Affairs Updates-Avian influenza Regulatory focus
Avian influenza Regulatory alert- 24 January 2006 US STATE DEPT 23 January 2006. United States Pursues Criminal Charges in Bird Flu Drug Fraud. The U.S. Food and Drug Administration (FDA) and federal law enforcement agencies are arresting people who are trying to sell bogus remedies or vaccines against avian influenza, also known as bird flu.

International Regulatory Affairs Updates-Avian influenza Regulatory focus
Avian influenza Regulatory alert- 20 January 2006 MaltaMedia By Ruth Davies Dec 22, 2005, 17:47 CET; Counterfeit Avian influenza drrugs alert Maltese website selling Tamiflu drug illegally

International Regulatory Affairs Updates-Avian influenza Regulatory focus
Avian influenza Regulatory Alert- 20 January 2006 San Francisco Chronicle; Diana Walsh, Chronicle Staff Writer; Monday, December 19, 2005
SOUTH SAN FRANCISCO Customs seizes fake Tamiflu Nation's first haul of bogus bird flu pills traced to China

International Regulatory Affairs Updates-Avian influenza Regulatory focus
Avian influenza Regulatory alert- 20 January 2006 ConsumerAffairs.com; 24 October 2005
FDA To Speed Up Tamiflu Production

International Regulatory Affairs Updates-Avian influenza Regulatory focus
Avian influenza Regulatory Alert- 20 January 2006 ConsumerAffairs.com; 26 November 2005

Governments Cracking Down on Internet Tamiflu Sales

International Regulatory Affairs Updates-Avian influenza Regulatory focus

International Regulatory Affairs Focus: Bird flu Regulatory Alert
Avian influenza Regulatory Alert - 12 January 2006 Today.Reuters; Thu Jan 12, 2006 2:44 PM GMT By Anna Mudeva. AMSTERDAM (Reuters) - The Dutch government wants to vaccinate its huge poultry population against bird flu in the face of growing fears of a major European outbreak, the farm ministry said on Thursday. Read Full Story: Dutch to fight bird flu by mass poultry vaccination

International Regulatory Affairs Focus: Bird flu Regulatory Alert
Avian influenza Regulatory Alert - 12 January 2006 Drug Discovery & Development; Cover Story; 09 January 2006. Fears of a possible avian flu pandemic spurred industry and government agencies to develop potential vaccines and work on updating production techniques to improve yields. Read full story: Forging an Avian Flu Shield

Avian influenza Regulatory Alert-12 January 2006
Avian influenza Regulatory Alert - 12 January 2006 DES PLAINES, Ill., Jan. 11 /PRNewswire/ American Society of Safety Engineers Offer Flu Infection Control Tips

Avian influenza Regulatory Alert-12 January 2006
Avian influenza Regulatory Alert - 12 January 2006

The Korea Times; By Cho Jin-seo; Staff Reporter

LG to Market 'Unproven' Anti-Bird Flu Aircons

International Regulatory Affairs Focus: Bird flu Regulatory Alert
Avian influenza Regulatory Alert - 12 January 2006
Yahoo/PRNews; Monday January 9, 3:00 am ET;Source: Juvaris BioTherapeutics, Inc. Juvaris BioTherapeutics Receives NIH Grant for Development of Influenza A Virus Vaccine. Program to Include Vaccine Against Avian Strain.

International Regulatory Affairs Focus: EMEA Update on Tamiflu
Tamiflu Adverse Events in the Pediatric Population

EMEA website; 17 November 2005
Posted: 08 January 2006

Avian Influenza- Tamiflu -EMEA's Update on Adverse Events among Children

International Regulatory Affairs Focus: PAHO Avian influenza Alerts
Pan American Health Organization (PAHO) Avian influenza Alerts;

PAHO.org; Date Posted: 08 January 2006

PAHO web resources on the dreaded Avian influenza virus (H5N1)

International Regulatory Affairs Focus: Counterfeit Bird Flu Medications
Fraudulent Avian Flu Therapies

MedWatch - The FDA Safety Information and Adverse Event Reporting Program; 29 December 2005; Date Posted: 08 January 2006:

FDA notified healthcare professionals and patients that it issued warning letters to nine companies marketing bogus flu products.

International Regulatory Affairs Focus
Avian influenza Regulatory Alert- 08 January 2006

European Medicines Agency
7 Westferry Circus, Canary Wharf, London; 27 October 2005

Ref. Doc.: EMEA/CHMP/339972/2005

Summary Report: Review on influenza antiviral medicinal products for
potential use during pandemic

International Regulatory Affairs Focus: WHO Europe on Influenza vs Avian influenza

International Regulatory Affairs Focus: Avian Influenza Fake Drugs
Avian Influenza Fake Drugs

FDA Press Release; 13 December 2005 Date Posted: 08 January 2006

FDA Acts to Protect Public from Fraudulent Avian Flu Therapies. FDA Warning letters to the nine affected Companies are listed below:

Additional information for consumers is provided on Reporting Unlawful Sales of Medical Products on the Internet and Preventing the flu

Avian influenza (H5N1) News Alert- 07 January 2006
Avian influenza (H5N1) deaths in Europe

Associated Press/Yahoo News
By ALEXANDER G. HIGGINS, Associated Press Writer
Sat Jan 7, 12:48 PM ET

WHO: Deaths in Turkey Were From H5N1 Flu

Avian influenza (H5N1) News Alerts- # 02--07 January 2006
First Avian influenza (H5N1) human case in Europe
WHO; Update 07 January 2006

Avian influenza situation in Turkey