On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
In life sciences manufacturing, inspections by the FDA, state regulators or other agencies are part of the job. But too often ...
The FDA issued a final rule which continues efforts to promote consistency in the regulation of devices and provides timelier introduction of safe and effective high-quality devices for patients.
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 ...
The Food and Drug Administration issued a warning letter to Philips citing significant violations at three of its medical device facilities. The inspections took place between January and March 2025 ...
Polymicro Technologies, a subsidiary of Molex, announced its registration and compliance with the U.S. Food and Drug Administration 21 CFR 820 Quality System Regulation. The Polymicro Technologies ...
The ICH and FDA guidance documents on Pharmaceutical cGMPs stress the importance of management's responsibility to meet customer needs by encompassing quality improvement through quality by design ...
(Reuters) - U.S. drug inspectors recently recorded several new quality- control problems at an Eli Lilly and Co plant that is already the subject of a federal investigation over manufacturing lapses, ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results