Medical Devices and Pharma
Medical device and pharmaceutical regulatory consulting and health safety informationWelcome 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
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The Latest Posts
FDA Approves New Imaging Drug Lumisight
A Significant Improvement for Surgical Oncology The U.S. Food and Drug Administration (FDA) has granted approval to LumiSight (pegulicianine) for use in adults undergoing breast lumpectomy, marking a significant advancement in surgical oncology. Lumisight, a...
FDA Issues Warning on Counterfeit Botox Products
Real Botox PackagingReal Botox Cosmetic PackagingReal Botox PackagingCounterfeit Botox Products The U.S. Food and Drug Administration (FDA) has issued a critical alert concerning the presence of counterfeit Botox products in various states, posing severe risks to...
FDA Approves XACT Carotid Stent System
A Breakthrough for Stroke Prevention Abbott Vascular Inc. has received FDA approval for its groundbreaking XACT Carotid Stent System, a significant advancement in stroke prevention technology. Approved on February 7, 2024, this innovative system offers new hope for...
FDA Approves Xolremdi for WHIM Syndrome
A Breakthrough for Rare Infections In a groundbreaking development, the U.S. Food and Drug Administration (FDA) has granted approval for Xolremdi (mavorixafor) capsules, marking a significant milestone in the treatment of WHIM syndrome. Let's delve into what this...
FDA Fast Track Program
For Serious Conditions - Unmet Medical Needs The FDA's Fast Track program is designed to facilitate the development and expedite the review of drugs and biologics intended to treat serious conditions and fill an unmet medical need. Following are key details of the...
FDA’s Orphan Drug Program
Expedite Development of New Orphan Drugs The FDA's Orphan Drug Program is designed to encourage the development of drugs and biologics for the treatment, diagnosis, or prevention of rare diseases or conditions, often referred to as orphan diseases. Here are the key...