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Archives for June 2009

Flu Vaccine Fact Sheet

H. Sandra Chevalier-Batik · June 30, 2009 ·

The Truth About The Flu Shot "By 1853, Parliament began passing laws to make the untested vaccine compulsory throughout the British Empire. Other countries of Europe followed suit. Once the economic implications of compulsory vaccinations were realized, few dared to disagree. … [Read more...] about Flu Vaccine Fact Sheet

Filed Under: Vaccination Policy Tagged With: American Thoracic Society’s 105th International Conference, Flu Shot, H1N1 "swine flu" virus, H1N1 andemic influenza preparedness efforts, H1N1 Influenza Vaccine Antigen and Adjuvant, inactivated flu vaccine Flumist, Project BioShield, The Cochrane Database of Systematic Reviews, WHO, WHO global influenza preparedness plan

FDA Has Issued Emergency Use Authorizations for Two Antiviral Treatments — Tamiflu (oseltamavir) and Relenza (zanamivir)

H. Sandra Chevalier-Batik · June 28, 2009 ·

Stockpiled Antivirals at or Nearing ExpirationDuring this public health emergency, the FDA has issued Emergency Use Authorizations that expand access to medical products that may become necessary. Two antiviral treatments covered by Emergency Use Authorizations, Tamiflu … [Read more...] about FDA Has Issued Emergency Use Authorizations for Two Antiviral Treatments — Tamiflu (oseltamavir) and Relenza (zanamivir)

Filed Under: Influenza A Virus H1N1 Strain Tagged With: FDA, FDA’s Emergency Operations Center, H1N1 andemic influenza preparedness efforts, Swine flu vaccine production, Tamiflu (oseltamavir) and Relenza (zanamivir)

FDA Safety Information and Adverse Event Reporting Program

H. Sandra Chevalier-Batik · June 27, 2009 ·

MedWatch Online Voluntary Reporting Form (3500) Click the BEGIN button to report serious adverse events for human medical products, including potential and actual product use errors and product quality problems associated with the use of: FDA-regulated drugs, biologics … [Read more...] about FDA Safety Information and Adverse Event Reporting Program

Filed Under: Women's Health Tagged With: FDA Adverse Event Reporting Program

FDA Produces 2009H1N1 Frequently Asked Quesations

H. Sandra Chevalier-Batik · June 26, 2009 ·

FDA Press Release 2009 H1N1 Flu Virus and Antivirals Questions and Answers Q: Do the FDA’s Emergency Use Authorizations for antiviral drugs (Tamiflu and Relenza) cover their use for both prevention and treatment? The EUAs for Tamiflu and Relenza cover the emergency use of the … [Read more...] about FDA Produces 2009H1N1 Frequently Asked Quesations

Filed Under: Influenza A Virus H1N1 Strain Tagged With: 2009 influenza pandemic, FDA, H1N1 andemic influenza preparedness efforts, H1N1 Flu, Public Readiness and Emergency Preparedness Act declaration for antivirals), Relenza, Shelf Life Extension Program (SLEP), Strategic National Stockpile, Swine Flu, Tamiflu

FDA is Finally Prosecuting Off-Lable Marketing of Pharmaceuticals

H. Sandra Chevalier-Batik · June 24, 2009 ·

The United States Attorney's Office District of Massachusetts FOR IMMEDIATE RELEASE JUNE 18, 2009 WWW.USDOJ.GOV/USAO/MA CONTACT: CHRISTINA DiIORIO-STERLING PHONE: (617)748-3356 E-MAIL: USAMA.MEDIA@USDOJ.GOV PHARMACEUTICAL COMPANY MANAGER SENTENCED FOR OFF-LABEL … [Read more...] about FDA is Finally Prosecuting Off-Lable Marketing of Pharmaceuticals

Filed Under: Big Pharma Watch Tagged With: Bextra, cardiovascular events, coronary artery bypass graft surgery, Cox-II inhibitor, distribution of a misbranded drug, FDA, Food and Drug Administration, MARY HOLLOWAY

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