Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Tom Freyne Recipient Title CEO Scope Health Inc 79 Madison Ave, Fl 8New York, NY 10016United States […]

Delivery Method: Via Email Reference #: 320-25-86 Product: Drugs Recipient: Recipient Name Mr. Jin Soo Baek Recipient Title Managing Director Daewoo Pharmaceutical Co., Ltd. 153, Dadae-ro, […]

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Susan K. Benton Recipient Title President Thea Pharma, Inc. 303 Wyman Street, Suite 205Waltham, MA 02451United States […]

Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 25-HFD-45-06-02 Product: Drugs Recipient: Mark J. Savant, M.D./San Francisco Research Institute 2435 Ocean AvenueSan Francisco, […]

Summary Company Announcement Date: July 11, 2025 FDA Publish Date: July 14, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Company closure and discontinuation […]

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

On This Page Date: September 19, 2025 Time: 9:00 a.m. – 1:00 p.m. ET Under the Biosimilar User Fee Act (BsUFA) reauthorization commitment letter for fiscal […]

For Immediate Release: July 10, 2025 The U.S. Food and Drug Administration (FDA) today published more than 200 decision letters, known as complete response letters (CRLs). […]

On This Page Date: August 25 – 28, 2025 Day1: Mon, Aug 25 2:00 p.m. – 05:00 p.m. ET Day2: Wed, Aug 27 9:00 a.m. – […]