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)
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FDA Produces 2009H1N1 Frequently Asked Quesations
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
FDA is Finally Prosecuting Off-Lable Marketing of Pharmaceuticals
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
FDA Warns Web Sites against Marketing Fraudulent H1N1 Flu Virus Claims
FDA NEWS RELEASE For Immediate Release: June 15, 2009 Media Inquiries: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA FDA Warns Web Sites against Marketing Fraudulent H1N1 Flu Virus Claims The U.S. Food and Drug … [Read more...] about FDA Warns Web Sites against Marketing Fraudulent H1N1 Flu Virus Claims
FDA Ongoing Safety Review Of Attention-Deficit/Hyperactivity Disorder Medications
Stimulant Medications used in Children with Attention-Deficit/Hyperactivity Disorder - Communication about an Ongoing Safety Review Products involved include: Focalin, Focalin XR (dexmethylphenidate HCl ); Dexedrine, Dexedrine Spansules, Dextroamphetamine ER, Dextrostat … [Read more...] about FDA Ongoing Safety Review Of Attention-Deficit/Hyperactivity Disorder Medications