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 […]

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 […]

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 […]

Applying for Membership on FDA Advisory Committees As part of the Food and Drug Administration (FDA)’s ongoing efforts to recruit qualified experts with minimal conflicts of […]

Summary Company Announcement Date: August 26, 2020 FDA Publish Date: August 26, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Product contains 1-propanol. Company […]

For Immediate Release: July 08, 2024 Today, the U.S. Food and Drug Administration is advancing its mission of ensuring the public has access to accurate, up-to-date […]

In fiscal year 2022, FDA’s Office of Orphan Products Development (OOPD) funded three natural history studies under the Orphan Products Grants program which serve to meet […]