[11-19-2024] The Food and Drug Administration is advising consumers not to purchase or use HON-E-LING, a product promoted for sexual enhancement on various websites, and possibly in some retail stores. This product was identified during an examination of …
Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research and Theresa Michele, M.D., Director, CDER Office of New Drugs’ Office of Nonprescription Drugs CDER Director, Patrizia Cavazzoni, M.D. Over-the-Counter (OTC) drugs have long …
Delivery Method: VIA Electronic Mail Reference #: 320-25-12 Product: Drugs Recipient: Recipient Name Mr. Pietro Giulio Orso Recipient Title Managing Director Originitalia SRL Vicolo Don Antonio Menin 6 36030 Caldogno VI Italy Issuing Office: Center for …
Delivery Method: Via Email Reference #: 320-25-11 Product: Drugs Recipient: Recipient Name Mr. Saurabh Bansal Recipient Title Managing Director Unexo Lifesciences, Private Limited B16 Sector 4 Bawana Industrial Area New Delhi 110039 Delhi India Issuing …
Delivery Method: VIA Electronic Mail Reference #: 320-25-09 Product: Drugs Recipient: Recipient Name Mr. Noel Wallace Recipient Title Chief Executive Officer Colgate-Palmolive/Tom's of Maine, Inc. 300 Park Avenue New York, NY 10022 United States Noel_ …
Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Mr. Xiangqi Zhang Recipient Title Vice General Manager Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd. No. 20 Daming Street Xiqing Qu Tianjin Shi, 300112 China jwhzxq@163.com …
Delivery Method: VIA UPS and Electronic Mail Reference #: 24-HFD-45-10-02 Product: Drugs Recipient: Richard W. Foltin, Ph.D. 1051 Riverside Drive New York, NY 10032-1007 United States Issuing Office: Center for Drug Evaluation and Research (CDER) United …
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 …
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 “ …
On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Public Law No. 116-136, 134 Stat. 281, 457) was signed into law. Section 505G of the CARES Act reforms and modernizes the OTC drug review process. It also includes …
Introduction Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical …
Antibiotics are powerful medications that save countless lives every day. But they’re not the answer for every illness. Antibiotics treat only some infections caused by bacteria – and none caused by viruses. Most often, antibiotics work by killing the …
Docket Number: No.: FDA-2024-D-4311 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research This guidance is intended to provide industry with answers to frequently asked questions (FAQs) and commonly faced issues that arise during …
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 …
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 …
For Immediate Release: November 15, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Next week, the World Health Organization’s Member State Mechanism on Substandard and Falsified …
On November 15, 2024, the Food and Drug Administration approved revumenib (Revuforj, Syndax Pharmaceuticals, Inc.), a menin inhibitor, for relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and …
Listen to the The Need for Artificial Intelligence in Pharmacovigilance and the Emerging Drug Safety Technology Program audio podcast. Podcast Transcript Dr. Weber: Welcome to the CDER Small Business and Industry Assistance (SBIA) Chronicles Podcast. …
On This Page Date: January 28 - 29, 2025 Day1: Tue, Jan 28 8:30 AM - 4:00 PM ET Day2: Wed, Jan 29 8:30 AM - 4:00 PM ET Agenda Visit CDER Small Business and Industry Assistance Page ABOUT THIS EVENT (Hosted by CDER SBIA) FDA’s Knowledge-aided Assessment and …
Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Office of the Commissioner Additional copies are available from: Office of Training and Communications Division of Drug Information, …
