Delivery Method: VIA UPS Reference #: 320-26-42 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Mr. Yanzhuan Zheng Recipient Title Owner/President Bio-Medical Pharmaceutical Manufacturing Corporation 4311 South […]

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name James Nabors III Recipient Title Manager Beach Weekend Management LLC dba Nic and Jet Fuel 119 Hollywood […]

Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 26-HFD-45-02-01 Product: Drugs Recipient: Mark S. Dacey, M.D. 425 South Cherry Street, Suite 907Denver, CO […]

Delivery Method: VIA UPS Reference #: 320-26-38 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Ms. Maria Esparza Recipient Title President and Owner Signature Formulations, LLC 5446 […]

The U.S. Food and Drug Administration (FDA) is providing this communication to increase awareness of recent updates to the product labeling of capecitabine (Xeloda) and fluorouracil […]

The Informed Consent Template1 is included as an example in the appendix of FDA’s guidance titled Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers […]

Docket Number: FDA-2026-D-0207 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The Food and Drug Administration (FDA, […]

Image Rare Disease News, Events & Reports by Year: 2025 | 2024 | 2023 | 2022 FDA Rare Disease Day FDA will host Rare Disease Day, […]

Image Rare Disease Drug Approvals  2025 | 2024 | 2023 | 2022 | 2021 This page describes select recent rare disease drug approvals announced by a […]