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Drugs in the News

September 5. FDA posts quarterly report of potential safety issues. FDA News

September 4. FDA announces that manufacturers of TNF-blocker drugs (Cimzia, Enbrel, Humira, and Remicade) must highlight the risk of fungal and serious opportunistic infections. Drug Information; FDA News

August 25. FDA updates the Information for Healthcare Professionals sheet for Tysabri (natalizumab). Drug Information

August 21. FDA issues an Early Communication About an Ongoing Safety Review of Ezetimibe/Simvastatin (marketed as Vytorin), Simvastatin (marketed as Zocor) and Ezetimibe (marketed as Zetia). Drug Information

August 18. FDA updates the Information for Healthcare Professionals sheet for Byetta (exenatide). Drug Information

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Featured Items

Prescription Drug User Fee Act (PDUFA)
FDA proposed recommendations to Congress for the next reauthorization of the Prescription Drug User Fee program which, if adopted, would significantly broaden and upgrade the agency's drug safety program, increase resources for review of television drug advertising, and facilitate more efficient development of safe and effective new medications for the American public.

National Drug Code Updates
National Drug code information and updating information
Prescription Drug Marketing Act (PDMA)
Drugs Marketed in the United States That Do Not Have Required FDA Approval
FDA has issued a guidance entitled “Marketed Unapproved Drugs--Compliance Policy Guide” designed to make sure that all drugs marketed in the U.S., prescription and over-the-counter, have been shown to be safe and effective.
Facts@FDA Download available Structured Product Labeling file.

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Structured Product Labeling (SPL) Resources
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