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 […]
July 9, 2024
Drug master files (DMFs) are submissions to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and […]
July 9, 2024
The spread of human immunodeficiency virus 1 (HIV-1) infections increased despite restrictions on the border between Mexico and the United States during the COVID-19 pandemic, according […]
July 9, 2024
Patients with treatment-refractory cancers who did not meet eligibility criteria for a pan-cancer clinical trial but received waivers allowing them to participate had similar outcomes to […]
July 9, 2024
Moving for any new opportunity in medicine can feel like starting a new life, not just a new job. This is especially true for residency or […]
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