Delivery Method: VIA UPS Reference #: 320-25-14 Product: Drugs Recipient: Recipient Name Mr. Shouquan Zhou Recipient Title General Manager Zhejiang Uniquality Nursing Products Technology Co., Ltd. […]

Delivery Method: VIA UPS Reference #: 320-25-19 Product: Drugs Recipient: Recipient Name Mr. Sung-chun Baik Recipient Title Chief Executive Officer LCC Ltd. 738-13 Samyang-roDaeso-myeonEumseong-gunChungcheongbuk-doSouth Korea Issuing […]

Docket Number: FDA-2022-D-2628 Issued by: Guidance Issuing Office Center for Devices and Radiological Health Center for Biologics Evaluation and Research Center for Drug Evaluation and Research […]

On This Page Date: January 10, 2025 Time: 9:00 AM – 4:30 PM ET What is an advisory committee? Advisory committees provide independent expert advice to […]

FDA’s curriculum materials are intended to help educate students in health care professional degree programs, for medicine, nursing, physician assistants, and pharmacy, as well as practicing […]

[11-27-2024] The Food and Drug Administration is advising consumers not to purchase or use LipoFit Turbo, a product promoted and sold for weight loss on various websites, […]

Generic Drug User Fee Amendments (GDUFA) Science and Research Priority Initiatives for Fiscal Year (FY) 2025 Download or Print (PDF – 150 KB) Consistent with FDA’s […]

Docket Number: FDA-1998-D-0021 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance provides revised recommendations on what chemistry, manufacturing, and controls (CMC) […]

Each year, FDA consults with industry and the public to develop a list of regulatory science initiatives on generic drugs in accordance with the Generic Drug User […]