Regulations and governmental guidance are only as good as the information the government receives about how the rules are likely to impact industry. The FDA is currently seeking the pharmaceutical industry’s input on two important topics:
- Remote cGMP Inspections
- Use of AI in drug manufacturing
The deadlines for submitting your comments are coming up soon.
Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications
Guidance Document; Comments due by November 21, 2023
Overview: The Draft Guidance provides insight into how the FDA is considering using "alternative tools" for remote inspections, including “Remote Regulatory Assessments,” “Remote Interaction Evaluations,” and the use of remote Subject Matter Experts.
FDA Summary: The purpose of this guidance is to provide information to applicants on how FDA intends to use alternative tools to assess manufacturing facilities identified in a marketing application, an abbreviated new drug application, a biologics license application, or a supplement to any of these types of applications. As part of the negotiations relating to the reauthorization of the Prescription Drug User Fee Act and the Biosimilar User Fee Act, the FDA agreed to issue guidance on the use of alternative tools to assess manufacturing facilities named in pending applications and to incorporate best practices from the use of such tools during the Coronavirus Disease 2019 (COVID-19) pandemic.
Click here to access the document and the online submission portal.
Artificial Intelligence in Drug Manufacturing
Discussion Document; Comments due by November 23, 2023
Overview: The FDA initially sought industry input way back in March about the use of AI in drug manufacturing. The comment period closed in May, but the level of input must have been insufficient, as the FDA has now reopened the public docket to allow additional time for comment. It is important to note that the FDA used the phrase “Regulatory Framework” when it noticed the public workshop it held recently with the Product Quality Research Institute – i.e., “Regulatory Framework for the Utilization of Artificial Intelligence in Pharmaceutical Manufacturing: An Opportunity for Stakeholder Engagement.” If you want to have some input, the time is now.
FDA Summary: The discussion paper presents areas for consideration and policy development identified by the Center for Drug Evaluation and Research (CDER) scientific and policy experts associated with application of artificial intelligence to pharmaceutical manufacturing. The discussion paper includes a series of questions to stimulate feedback from the public, including CDER and the Center for Biologics Evaluation and Research stakeholders.
Click here to access the document and the online submission portal.
Michelle Fishburne is the Associate Director of Public Relations for Quality Executive Partners. Her experience as an international corporate attorney, educator, and public relations professional provides her with a unique understanding of how regulatory compliance, education and training best practices, and thought leadership can advance the pharma and biotech industries.
