FDA’s Human Drug Compounding Progress Report: Three Years After Enactment of the Drug Quality and Security Act (January 2017)Download PDF (PDF – 1 MB)Text Version Compounding is […]

Subscribe for Updates Health Fraud Scams FDA has identified condition-specific medication health fraud scams that can pose significant risks to consumers. Understanding these risks can help […]

Subscribe for Updates Medication health fraud includes the marketing of medication products with unproven, false, or misleading claims about those products’ ability to diagnose, cure, mitigate, […]

Subscribe for Updates Medication health fraud presents serious risks to the well-being of individuals and the public. The FDA employs a multi-faceted approach to protect public […]

FDA offers a variety of materials in multiple formats and languages to help promote understanding of biosimilars and interchangeable products. Explore the available resources FDA has […]

What are the facility fee types under GDUFA III?There are three types of facility fees: (1) an active pharmaceutical ingredient (API) facility fee; (2) finished dosage […]

Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation; or Drug Product The Generic Drug User Fee Amendments (GDUFA) include provisions for […]

Delivery Method: VIA EMAIL CONFIRMED DELIVERY Product: Drugs Recipient: Recipient Name Ms. Sally A. Cook Recipient Title President Optikem International Inc. 2172 South Jason StreetDenver, CO […]

Delivery Method: VIA EMAIL WITH READ RECEIPT Product: Drugs Recipient: Recipient Name Federico M. Gomez Recipient Title Co-President Laboratorio Magnachem International Avenida Jose Francisco PenaEsquina Calle […]