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-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Drug Evaluation and Research The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “Symptomatic Nonerosive …
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 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 …
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 View Product Photos …
For Immediate Release: December 09, 2025 The U.S. Food and Drug Administration today approved Augmentin XR (amoxicillin-clavulanate potassium) under the Commissioner's National Priority Voucher (CNPV) pilot program, marking the first approval achieved …
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 …
Summary Company Announcement Date: December 05, 2025 FDA Publish Date: December 09, 2025 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential or Undeclared Allergen – Undeclared Milk Company Name: Lil’ Turtles …
Delivery Method: VIA UPS Return Receipt Requested Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Venkata R. Gogineni, Ph.D. Seaway Pharma Inc. 5 County Route 42 Massena, NY 13662 United States Issuing Office: Office of Manufacturing …
Delivery Method: Via UPS and EMAIL Signature Required Product: Biologics Recipient: Recipient Name Bruce R. Werber, DPM Recipient Title Chief Executive Officer and Founder BioXtek LLC 316 NE 1st St Pompano Beach, FL 33060 United States docw@bioxtek.com …
Delivery Method: Via Electronic Mail - Return Receipt Requested Reference #: 320-26-16 Product: Drugs Recipient: Recipient Name Mr. Randy D. Stevenson Recipient Title President DeVere Manufacturing Inc. 1923 Beloit Avenue Janesville, WI 53546 United States …
Delivery Method: VIA UPS Reference #: 320-26-21 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Mr. Luis F Salazar Recipient Title President/CEO CDL Services, Inc. DBA Technichem 3800 E Miraloma Avenue Anaheim, CA 92806 United States …
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