FDA protocol deviation guidance could go further
The US Food and Drug Administration has released draft guidance on protocol deviations, but experts say it could go further.
Leadership Success Story: Abhishek Pandurang Benke's Medical Device Innovation Journey
The amazing success of the Post-Operative Wound Drainage System project is a monument to strategic leadership and regulatory knowledge in the complicated world of medical device development, where ...
Image Analysis Group Announces Release of DYNAMIKA V.7, their Award-Winning Cloud Platform for Clinical Trial Imaging
Image Analysis Group (IAG), a leading imaging Clinical Research Organization (iCRO), today announced the release of their ...
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Key trends shaping pharmaceutical operations in 2025
The industry is grappling with significant market shifts amidst emerging technologies and changing demands. Companies are now producing increasingly personalised and sophisticated therapies, ...
Spectrum Advanced Manufacturing Technologies, Inc., An Ocutrx Company, Achieves Globally Recognized AS9100 Certification For Aerospace Manufacturing
The AS9100 certification includes certification to ISO 9001:2015 quality standards. ISO is an International Standardization ...
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The Strangest International Food Recalls In History
Food recalls can cause huge problems, and those problems aren't confined to the U.S., either. These are some of the strangest ...
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AI drives digital innovation in healthcare
In digital healthcare, AI drives innovations and improves patient outcomes by making processes more efficient.
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Final FDA SIUU Guidance: Understanding the Key Updates and Resources
In the final days of the Biden Administration, the United States Food and Drug Administration (FDA) issued final guidance on ...
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Decentralized clinical trials: FDA guidance and the ‘new modus operandi’
The COVID-19 pandemic forced investigators conducting clinical trials to use decentralized elements, such as telehealth, to ...
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Navigating FDA from 2024 into 2025 Human Foods Program
FDA Restructures its Food Resources Although there were a number of significant new regulations, the most significant food ...
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FDA Dumps Trio of Device-Related Guidances Prior to Administration Change
Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were ...
US FDA identifies cybersecurity risks in certain patient monitors
The U.S. Food and Drug Administration (FDA) said on Thursday it had identified three cybersecurity risks associated with certain patient monitors from Contec and Epsimed and urged healthcare ...