Market opportunities arise in providing solutions for cGMP software verification and validation, addressing increased FDA scrutiny. Demand exists for expertise in FDA guidelines, risk management ...
Embrace Computer Software Assurance (CSA) for modern life-sciences by focusing on meaningful evidence rather than burdensome documentation. This approach enhances efficiency, aligns with FDA ...
Insurers and payers are inappropriately using a years-old FDA birth-control chart to limit access to novel contraceptives as the reproductive rights landscape shifts nationwide, consumer advocates and ...
Physiologic monitoring devices are so ubiquitous in hospitals that it’s difficult to recall a time without them. The success of integrating this technology into patient care as a regular part of the ...
A plan to chart the routes of transmission for Salmonella species is the reason for a new cooperative agreement between the U.S. Food and Drug Administration (FDA) and North Carolina State University ...
We believe the recent positive feedback from the FDA concerning scPharma's Furoscix label expansion into chronic kidney disease (CKD) signals a propitious trajectory for the product. We highlight that ...
Editor’s note: The Food and Drug Administration posted this “FDA Voice” column July 14 under the title “Charting a Path Forward on Food Safety, Nutrition and Animal Health.” It was co-authored by ...
In the world of biopharmaceutical innovation, 2024 will be remembered as CRISPR’s breakout year. In the spring, five patients with sickle cell disease began treatment with Casgevy, the first ...
On July 13, 2011, FDA Commissioner Margaret Hamburg restructured the FDA organization charts. The new organizational alignments more accurately reflect the agency’s responsibilities, subject matter ...
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