Rogue online pharmacies offer potentially dangerous prescription drugs to U.S. consumers. FDA has issued warning letters informing the website operators that they are engaged in illegal activity in violation of the U.S. Federal Food, Drug, and Cosmetic Act
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FDA Commissioner's National Priority Voucher Program. The Commissioner's National Priority Voucher Program offers an unprecedented opportunity to reduce drug and biologic review times from 10-12 months to just 1-2 months.
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The 21st Century Cures Act formally established a multi-step process for Drug Development Tools (DDT) qualification. Qualification of a DDT is for a specific context of use (COU), and the qualified DDT may be used for the COU by any person in drug or biologics development.
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The U.S. Food and Drug Administration approved Lipfendra (enlicitide), the first oral inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9), as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C), or “bad” cholesterol, in adults with hypercholesterolemi
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Novel Drug Approvals for 2026
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Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)
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Human drug import information including PLAIR, safe importation action plan, and personal importation policy.
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Want to know what's new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc.
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Drug Trials Snapshots: breaking down the what, how and why. Drug Trials Snapshots are part of an overall FDA effort to make demographic data more available and transparent.
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eCTD Submission Standards
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On July 23-24, 2026, the Committee will discuss bulk drug substances being considered for inclusion on the 503A Bulks List.
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Drug Trials Snapshots: ZYCUBO

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