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 ...
The US Food and Drug Administration has released draft guidance on protocol deviations, but experts say it could go further.
InstantGMP™, a leader in fully integrated GMP-compliant software solutions for pharmaceutical manufacturing, proudly announces its new partnership with Corsair Pharma, an innovative biopharmaceutical ...
Getting a medical diagnostic tool to market can take between three to seven years due to the strict regulatory requirements.
In this interview, we explore the key changes shaping the pharmaceutical industry, maintaining compliance across global ...
On January 6, 2025, the FDA issued draft guidance on applying artificial intelligence to drug and biologics development, responding to a marked uptick in AI-based regulatory submissions. For the ...
The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: ...
Companies say they are working to update their products to comply with the Food and Drug Administration's decision Wednesday to ban the artificial food dye Red 3, after the agency said it was ...
The FDA is amending its color additive regulations to no longer allow for the use of Red No. 3 in food and ingested drugs in response to a 2022 color additive petition. The petition requested the ...
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