This new paper on AI and machine learning (ML) in drug development includes the use of any software that is regulated as a medical device for the drug development process. Indications are that such a software development project may require deep pockets.
The FDA has released a framework for the use of digital health technologies (DHTs) in the development of pharmaceuticals and biologics, but the FDA’s Center for Devices and Radiological Health (CDRH) will be intimately involved in this project.
The FDA has released a discussion paper on the use of artificial intelligence (AI) in the drug manufacturing process, raising a host of questions about issues such as the use of cloud services for manufacturing data management. Perhaps the key consideration posed by the paper is whether AI will enable the broad adoption of advanced drug manufacturing, which the FDA has been trying to encourage for nearly 20 years.
The FDA’s risk evaluation and mitigation strategy (REMS) requirements are among the most demanding of a pharmaceutical or biotech manufacturer’s postmarket requirements, and it is important to plan adequately for these programs, given the cost of a failed first attempt.
The FDA has released a second guidance from the International Council for Harmonization (ICH) related to analytical methods used in drug products, which is open for comment through Sept. 28, 2022. This latest version of the ICH Q2 series of guidances offers substantially greater detail than the previous version, suggesting that managers of drug manufacturing facilities should begin examining this policy on analytical methods validation to ensure the facility is prepared for the final version.
Electronic Quality Management System
Enzyme eQMS is flexible and scalable, making it easy to use for startups, yet configurable to meet the needs of the most complex enterprise
