On March 18 th, the FDA published draft guidance on validating new approach methodologies (NAMs), including complex in vitro models (CIVMs). For a field long operating without a clear regulatory ...
The FDA recently issued draft guidances for the use of AI in medical devices, drugs, and biologics. The guidances emphasize the need for comprehensive AI policies addressing risk evaluation, data ...
Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...
In biopharmaceutical manufacturing, consistency is vital but hard to achieve. Turning raw materials into safe, high-quality medicines requires stable processes. However, the living cellular expression ...
Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the ...
The US Food and Drug Administration (FDA) on Wednesday issued two draft International Council for Harmonisation (ICH) guidelines covering safety data collection and bioanalytical method validation for ...
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