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 ...
According to the Food and Drug Administration (FDA), the traditional paradigm of medical device regulation was not designed for adaptive artificial intelligence and machine learning technologies. As a ...
FREMONT, Calif.--(BUSINESS WIRE)--Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified therapeutics company, announced today it has entered a definitive agreement with Scorpius BioManufacturing ...
We’ve all heard process validation horror stories. Validations can take years. Creeping elegance can take over. Product launches can be stopped in their tracks. When implemented correctly, however, ...
Artificial intelligence (AI) has practically limitless applications in healthcare, ranging from auto-drafting patient messages in MyChart to optimizing organ transplantation and improving tumor ...
The Company has reviewed the AI request and is in the process of responding so that the FDA can restart the review clock. As a result of this process, although the FDA is required to review and ...
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