Med Device Online18h
Mastering FDA Inspections: The Prep Work For Regulatory Success
In the medical device industry, FDA inspections are not a regulatory hurdle — they are a powerful tool for improving product ...
The Week10d
WHO Prequalification - exploring opportunities and challenges to Indian IVD manufacturers
Mitigating diseases which have significant societal impact starts with an early and accurate diagnosis. Ensuring access to safe, appropriate and ...
The National Law Review15d
Legislators Introduce Feed Lot Testing Bill
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up to receive our free e-Newsbulletins Some states have laws and ethical rules regarding solicitation and ...
National Fisherman15d
FDA falls short on foreign shrimp inspections
The dramatic number of FDA inspections of domestic seafood producers, like these in Bayou la Batre, compared to the foreign producers responsible for 94 percent of the seafood Americans eat. Photo by ...
UPI17d
FDA OKs clinical trials for pig kidney transplants in people
The U.S. Food and Drug Administration has approved the first-ever clinical trials testing pig kidney transplants in people with kidney failure, marking a major step forward in cross-species ...
Yahoo Finance22d
FDA Inspections Seminar: Fundamentals and the Ground Rules on How to Prepare for and Survive an FDA Inspection (ONLINE EVENT: February 24-25, 2025)
Dublin, Jan. 30, 2025 (GLOBE NEWSWIRE) -- The "FDA Inspections: From Site Preparation to Response" training has been added to ResearchAndMarkets.com's offering. This is a practical, hands-on two-day ...
Europa22d
CE marking
Many products require CE marking before they can be sold in the EU. CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental ...
The Hindu23d
Aurobindo Pharma shares decline after U.S. FDA inspection report to subsidiary’s API plant
The U.S. FDA inspection of Unit-2, the API manufacturing facility of Apitoria Pharma in Jinnaram Mandal, Sanga Reddy district, conducted from September 23-27, had concluded with the regulator ...
CNN24d
FDA approves Ozempic to reduce risks from chronic kidney disease in diabetes patients
The new indications, approved Tuesday by the FDA, make Ozempic the most broadly indicated drug in its class, with the largest set of specific medical conditions that it may be prescribed to treat.
Acsh.org24d
FDA’s Failures in the Infant Formula Debacle Cry Out for Reform
Inefficiencies in the FDA’s inspection procedures further compounded the issue. During a subsequent inspection at Abbott’s Sturgis facility in September 2021, a new consumer complaint related to a ...
medtechdive25d
FDA webpages on clinical trial diversity removed after Trump orders
It’s not clear if the changes are temporary or if the pages will be restored. When asked about the removed webpages, an FDA spokesperson directed MedTech Dive to contact the Department of Health and ...