July 9, 2024
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 […]
July 9, 2024
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 […]
July 9, 2024
Bacterial and nonbacterial components of the gut microbiome and their function can accurately differentiate children with autism spectrum disorder (ASD) from neurotypical children, new research shows. […]
July 9, 2024
WASHINGTON, DC — The chronic, excessive fragility of aging and sun-damaged skin has a name in the medical literature: dermatoporosis. This identification is helpful because it […]
July 9, 2024
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 […]
July 9, 2024
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 […]
July 9, 2024
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 […]
July 9, 2024
Delivery Method: VIA EMAIL WITH READ RECEIPT Reference #: 320-24-49 Product: Drugs Recipient: Recipient Name Mr. Kwangjeon Lee Recipient Title Manager reBom Co., Ltd. 6 Myeonghaksandanseo-roYeondong-myeonSejong30068South […]
July 9, 2024
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 […]