Pharma, biopharma, and medical device makers should watch out for these perennial problems, which include inadequate ...
US Food and Drug Administration. guidance for industry: Q10 quality systems qpproach to pharmaceutical cGMP regulations (FDA, Rockville, MD, September 2006).
Food companies criticize the science supporting front-of-package labeling, delay public consultation periods, push for their ...
The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some ...
GlobalData on MSN2d
FDA grants 510(k) clearance to GE HealthCare’s updated ultrasound systems"FDA grants 510(k) clearance to GE HealthCare’s updated ultrasound systems" was originally created and published by Medical Device Network, a GlobalData owned brand. The informa ...
The FDA warned the nation about the growing vulnerability of the medical device supply chain and its effects on public health, particularly among pediatric patients, in a Jan. 16 news release.
drug quality, or the reliability of study results. The draft focuses on the use of AI models for drugs but mentions that it may also be relevant to medical devices, particularly those intended to ...
20% of bioreactor runs at the Genzyme facility failed due to contamination or quality issues over 2.5 years. FDA identified 84 overdue deviation investigations, some exceeding 180 days ...
On Monday, the FDA classified the First Quality Produce cucumber recall as ... such as the elderly or those with weakened immune systems.
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