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 ...
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 company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek ...
Medical device maker Dexcom said it has received a warning letter from the U.S. Food and Drug Administration following ...
The latest Comptroller and Auditor General (CAG) of India's Performance Audit Report has revealed severe deficiencies in ...
The draft guidance addresses concerns that pulse oximeters are less accurate for people with dark skin tones. Experts raised ...
WSPA Spartanburg on MSN1d
SC Bill could Affect Vaping RegulationsA new bill would, if passed, force businesses that sell vaping products to have guidelines and regulations about what can be ...
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