Medical Devices and Pharma
Medical device and pharmaceutical regulatory consulting and health safety informationFDA and global regulatory affairs, consumer health, and professional development
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Urgent Recall Alert for Methocarbamol Injection by Eugia US LLC
Attention Consumers, Healthcare Providers, and Distributors: Eugia US LLC, formerly known as AuroMedics Pharma LLC,...
Amneal Recalls Vancomycin Hydrochloride Oral Solution
Some bottles may be super potent Attention Patients, Health Professionals, and Pharmacies: Amneal Pharmaceuticals issued a...
Electrical Stimulation Devices – ESDs
Devices use controlled electrical pulses Electrical stimulation medical devices are sophisticated tools designed to deliver...
FDA Proposes Ban of Certain ESDs
Ban would affect devices used to treat aggressive/self-injurious behavior In a landmark move, the U.S. Food and Drug...
US Agent and Correspondent Services
Your Regulatory Presence in the United States Entering and maintaining access to the U.S. market requires more than...
FDA Approves Thoracic Stent Graft System
FDA Approves RelayPro Thoracic Stent Graft System for Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers...
Welcome to Medical Devices and Pharma, a website dedicated to providing timely and relevant medical device and pharma information to the regulated medical device and pharmaceutical industries, and consumers of those products.
Our goal is to provide organized, clearly written information from regulatory affairs and consumer perspectives.
- Key information from the Food and Drug Administration (FDA), the federal regulatory agency responsible for providing oversight over the industries and assuring the safety and efficacy of their products.
- Regulatory services for compliance, market access, and crisis management
- Information about innovation, including new products cleared for use in the U.S. market.
- News stories with topics ranging from product issues to market trends.
Perhaps most importantly, we will strive to maintain vigilance over product issues and their impacts. Check back here for consumer news, product alerts, and current litigation.
Medical Devices
Pharma