The founding director of the FDA’s Office of Biotechnology writes that, with FDA approval of medications ultimately vested ...
THE Food and Drug Administration (FDA) has launched an online application process for Certificate of Medical Device Notification (CMDN) for Class A ...
MethodSense says it is helping pulse oximeter manufacturers with FDA draft guidance to enhance accuracy across diverse skin ...
As of late February, there were 147 medical device recall events and 20 of them, or 13.6%, were Class I, according to a Modern Healthcare report.
To support the implementation of DPCO, 2013, the Integrated Pharmaceutical Database Management System (IPDMS) was developed.
FDA nominee Martin Makary was asked about abortion drugs, vaccine panels during a Senate hearing on his bid to lead the ...
The global preclinical medical device testing services market is poised for steady expansion, with revenue expected to grow from USD 1,696.0 million in 2025 to USD 2,842.1 million by 2035, at a CAGR ...
1d
The "FDA Inspection" training has been added to ResearchAndMarkets.com's offering. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no ...
The U.S. Food and Drug Administration has approved Medtronic's deep brain stimulation system for use in patients with Parkinson's disease, the medical device maker said on Monday.
The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek ...
New SEC filings from pharmaceutical companies reveal Donald Trump and Elon Musk’s cost-cutting measures could slow drug ...
Because AI is so new, a lot of the FDA employees working ... of 40 working on reviewing imaging devices, as well as 40 people on a research team that helps regulatory staff understand AI and ...
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