Recipient: Recipient Name David A. Ricks Recipient Title Chief Executive Officer Eli Lilly and Company Lilly Corporate Center Indianapolis, IN 46285 United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States RE: NDA 217806 …
Recipient: Recipient Name David A. Ricks Recipient Title Chief Executive Officer Eli Lilly and Company Lilly Corporate Center Indianapolis, IN 46285 United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States RE: NDA 217806 …
Recipient: Recipient Name Josh Disbrow Recipient Title Chief Executive Officer Aytu Biopharma 7900 E. Union Avenue, Suite 920 Denver, CO 80237 United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary Issuing …
Recipient: Recipient Name Josh Disbrow Recipient Title Chief Executive Officer Aytu Biopharma 7900 E. Union Avenue, Suite 920 Denver, CO 80237 United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary Issuing …
Delivery Method: VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary Issuing Offices WARNING LETTER September 9, 2025 FWD: This letter is to advise you …
Recipient: Recipient Name Maziar Mike Doustdar Recipient Title President and Chief Executive Officer Novo Nordisk Inc. 800 Scudders Mill Road Plainsboro, NJ 08536 United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States …
HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “ …
Docket Number: FDA-2025-D-0346 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “Erosive Esophagitis: …
Docket Number: FDA-2025-D-0331 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “Symptomatic Nonerosive …
Docket Number: FDA-2025-D-1308 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Disseminated …
Delivery Method: Via Email Product: Drugs Food & Beverages Issuing Office: Human Foods Program United States July 17, 2025 WARNING LETTER CMS #692733 Dear Mr. Connelly: The U.S. Food and Drug Administration (FDA) conducted an inspection of your …
Delivery Method: VIA Electronic Mail Reference #: 320-25-107 Product: Drugs Recipient: Recipient Name Ms. Ayna Bian Recipient Title Quality Dept. Manager Yangzhou Yulou Paper Products Co., Ltd. No.888 Jinbao West Road Baoying Xian Yangzhou Shi Jiangsu …
Delivery Method: VIA UPS Reference #: 320-25-108 Product: Drugs Recipient: Recipient Name Ms. Rachel Rendel Recipient Title Founder/Owner Columbia Cosmetics Manufacturing Inc. 1661 Timothy Dr. San Leandro, CA 94577-2311 United States Issuing Office: Center …
Delivery Method: Via Mail Product: Drugs Food & Beverages Recipient: Recipient Name Katrina Johnson Blue Forest Farms, LLC 400 Madison Avenue New York, NY 10017-1909 United States info@blueforestfarms.com Issuing Office: Human Foods Program United …
Speech by Grace Graham Deputy Commissioner for Policy, Legislation, and International Affairs - Food and Drug Administration Good afternoon. On behalf of the FDA, I am pleased to welcome you to the sixth Online Controlled Substances Summit. Thank you for …
For Immediate Release: September 12, 2025 The U.S. Food and Drug Administration today announced the launch of the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products, an interactive tool designed to facilitate the public’s …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement Summary Company …
CDER Researchers have been investigating how pharmacokinetic (PK) modeling can support a determination of bioequivalence (BE) for topical drug products. In the case of a generic diclofenac sodium topical gel, 1%, CDER found that physiologically based …
Submit an annual report to FDA Search the annual reporting database Download the database file Annual Licensure Reporting Requirements Wholesale drug distributors and third-party logistics providers must be appropriately licensed and report licensure …
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