Medical Devices and Pharma
Medical device and pharmaceutical regulatory consulting and health safety informationHeadlines
No Results Found
The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.
No Results Found
The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.
No Results Found
The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.
No Results Found
The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.
No Results Found
The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.
No Results Found
The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.
Latest Posts
Urgent Action Required – Baxter LIFE2000 System
Software issue can cause potential harm or death On March 10, the US Food and Drug Administration (FDA) announced that Baxter International Inc. has issued an urgent medical device correction for its LIFE2000 Ventilation System. An issue with the device’ software may...
FDA Approves Rukabia for HIV Treatment
The U.S. Food and Drug Administration (FDA) on December 22, 2022 announced the approval of a new HIV drug called Rukobia (fostemsavir) for adults living with HIV who have limited treatment options. This drug is the first in a new class of HIV medications known as...
FDA Warning Letter to Jackson Clinic
Warning Letter Sites Violations of Law In early February of this year, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Jackson Health & Wellness Clinic. The business was cited for several violations related to its marketing and...
FDA Approval for Cancer Treatment Aid
The Food and Drug Administration (FDA) on 12 December 2022 announced the approval of Agilent's Resolution CTDX FIRST, a new in vitro diagnostic (IVD) medical device for use in the detecting a specific mutation in the KRAS gene in circulating cell-free DNA. This test...
FDA Accelerated Approval for Alzheimer’s Disease Treatment
The US Food and Drug Administration (FDA) announced on 06 January, 2023 that it had granted accelerated approval for the Alzheimer's disease treatment Leqembi. This is a significant milestone in the fight against Alzheimer's, a debilitating and progressive brain...
FDA Posts Warning Letter to MicroVention Costa Rica
Identifies several violations of the FD&C Act and QSR On February 7, FDA issued a warning letter it had sent to MicroVention Costa Rica SRL on September 30, 2022. The company is a subsidiary of MicroVention Inc., a medical device company based in Tustin,...
Available in paperback and eBook formats on Amazon.
Click on the image or this link to see the book on the Amazon website.
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