Information for Industry

Center for Drug Evaluation and Research, U.S. Food and Drug Administration

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Drugs in the News

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

August 12. FDA issues an Information for Healthcare Professionals sheet for Naltrexone. Drug Information

August 8. FDA issues an Information for Healthcare Professionals sheet for Amiodarone and Simvastatin. Drug Information

July 30. FDA issues Complete Response letters ordering Safety Labeling Changes under FDAAA for Aranesp, Epogen, and Procrit. Drug Information

July 9. FDA revises its process for responding to drug applications. FDA News

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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.

Recent Guidances

Structured Product Labeling (SPL) Resources

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Search for Brand Name and Generic Drugs
current and archival drug labels, drug approval histories, and more