Information for Industry

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

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Drugs in the News

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

July 8. FDA issues an Information for Healthcare Professionals sheet for fluoroquinolone antimicrobial drugs. Drug Information

June 30. FDA approves the first generic versions of Risperdal (risperidone) tablets to treat schizophrenia, bipolar disorder, and other psychiatric conditions. FDA News

June 17. FDA warns individuals and firms to stop selling fake cancer "cures." FDA News

June 16. FDA issues an Information for Healthcare Professionals sheet for antipsychotics. 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.

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