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 ...
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
MDR, MDSAP, and FDA audits demand rigorous preparation, lifecycle traceability, and risk-based compliance for global market ...
A structured data ownership model—rooted in ICH GCP principles, supported by MHRA and FDA interpretations, and documented in validated system specifications—will enable sponsors to maintain compliance ...
DexCom said that on Tuesday it received a warning letter from the U.S. FDA following inspections at its facilities in San Diego, Calif., and Mesa, Ariz. related to concerns about manufacturing ...
In today’s world – whether at work or at home – I’d be lost without the smartphone that helps me do so much more than just communicate. It knows where I am now and how to get where I want to be next.
FDA slaps China-based API makers with separate warning letters outlining quality, testing shortfalls
A pair of Chinese manufacturers with active pharmaceutical ingredients that were previously shipped to the U.S. have landed in the FDA’s crosshairs thanks to quality shortfalls, poor testing standards ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback