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 ...
Healio9h
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 ...
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The US Food and Drug Administration has released draft guidance on protocol deviations, but experts say it could go further.
Corsair Pharma Partners with InstantGMP® to Ensure Quality for Clinical Trials
InstantGMP™, a leader in fully integrated GMP-compliant software solutions for pharmaceutical manufacturing, proudly announces its new partnership with Corsair Pharma, an innovative biopharmaceutical ...
JD Supra3d
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 ...
JD Supra6d
FDA Finalizes Guidance on Communications Regarding Unapproved Uses of Medical Products
On January 7, the U.S. Food and Drug Administration (FDA) finalized its October 2023 guidance document titled “Communications From Firms to ...