RA/QA News Roll: Mid July 2023
Here's what's happening at FDA and across the broader life science RA/QA space.
This is our biweekly recap of news and industry happenings curated for our paid subscribers. Our goal is to bring you the headline news as well as the stories, research, and insights that might be harder to find.
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Here are some key items from the past couple of weeks.
FDA has recently published a draft guidance on postmarketing studies and trials mandated as a condition of approval, particularly for drugs that have received accelerated approval. The guidance provides clarity on what would constitute a "good cause" for not fulfilling these requirements. It aims to assist stakeholders in understanding the circumstances under which the FDA may consider modifying or waiving postmarketing study commitments. It addresses the criteria for evaluating and determining good cause and provides examples of situations that may meet this standard.
FDA has released a new draft guidance document addressing manufacturing changes and comparability specifically for cell and gene therapy products. This topic has been a source of concern for life sciences companies, as they need to ensure that making changes to their products during clinical development does not require repeating every pre-clinical test. The draft guidance provides insights and recommendations to assist companies in navigating these challenges. It offers guidance on approaches and considerations for assessing the impact of manufacturing changes and establishing comparability for cell and gene therapy products.
CDER recently revised its MAPP (Manual of Policies and Procedures) pertaining to the Office of Pharmaceutical Quality's (OPQ) Risk-based Site Selection Model for current good manufacturing practice (cGMP) inspections. According to the document’s change control table, it was updated to “include FDORA 2022, CARES Act, and quality system effectiveness; updated OS to OQS; made nonsubstantive, editorial changes.” The revised MAPP includes a few updates compared to the original 2018 version to reflect recent legislation. For instance, the FDORA introduced a new risk factor for FDA inspections: the compliance history of establishments in the country or region where they are located. As a result, the MAPP now considers both the compliance history of establishments in the country or region and the history of violations related to products exported from that area. Additionally, the MAPP incorporates the risk factor of "patient exposure" due to the information sponsors are now required to submit to the FDA under the Coronavirus Aid, Relief, and Economic Security (CARES) Act. Overall, these updates align the MAPP with recent legislative changes.