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Under Section 3213 of Food and Drug Omnibus Reform Act, the U.S. Food & Drug Administration (“FDA” or the “Agency”) is required to establish the Advanced Manufacturing Technologies...
The U.S. Food and Drug Administration (FDA) recently issued two discussion papers on the use of Artificial Intelligence (AI) and Machine Learning (ML) in the development of drug and...
FDA gave approval of their first drug on May 8th, 2023. The company is now finalizing its drug launch in the coming months. Click here to read more on EYEN stock.
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The best practice approach to effectively handling a data security incident starts with a proactive response plan. But when the inevitable occurs, will your plan stand up to the test?...
FDA Steps Up Support For Advanced Manufacturing Technologies The latest article by FDA Commissioner Hahn 1 is one of a string of communications and guidances emphasizing the agency’s support for the adoption of advanced manufacturing technologies (AMTs) and processes. The FDA has defined advanced manufacturing as new and emerging approaches for the production of medical technologies that can improve drug quality, address shortages of medicines, and speed time-to-market. The agency recognizes that AMT subsumes a broad swath of production techniques, including: The integration of novel techno...