RA/QA News Roll: Mid January 2024
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 and the stories, research, and insights that might be harder to find.
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We’ve also added emojis to our links to denote pharma/biologic items (💊) from device/diagnostic/digital health items (💉) when there’s a clear relevance to only one sector.
Here are some key items from the past couple of weeks.
FDA Guidances and Related Documents
In December, the FDA released a draft report and plan regarding best practices for FDA guidance documents. The agency was mandated to publish this document by the Food and Drug Omnibus Reform Act (FDORA) of 2022. The document highlights that the agency is exploring ways to simplify regulatory submission processes by revising and issuing guidance documents, as well as adopting innovative approaches to guidance development. The document also invites public feedback on six important aspects related to guidance development.
A highly anticipated guidance has been released regarding potency assurance for cellular and gene therapy products. Determining the potency of these products, distinguishing between those that are potent and those that fall short or are subpotent, poses a substantial challenge for developers of CGT products. This topic has been a frequent subject of discussion at Town Hall-style meetings organized by CBER's Office of Therapeutic Products (OTP), often referred to as the agency's "Super Office" for cell and gene therapy. 💊
The FDA has issued new guidance specifically aimed at small entities—specifically the FDA's recent rule concerning direct-to-consumer advertising and the clear, conspicuous, and neutral presentation of the major statement. The FDA's rule becomes effective in March 2024; this guidance was crafted to assist companies, especially small ones, in understanding how to comply with the rule effectively.
The FDA recently released a guidance document concerning the viral safety evaluation of biotechnology products originating from human or animal cell lines. This guidance document aligns with the ICH Q5A(R2) guideline, which the European Medicines Agency adopted just last week. 💊
The FDA updated an October 2023 draft guidance focusing on quality considerations for topical ophthalmic drug products. In recent months, the FDA has issued multiple warnings and recall notices related to eye drops. The updated draft guidance now incorporates a new section dedicated to microbiological considerations and product sterility. This addition appears to be a direct response to address the concerns raised by the recalls of these products. 💊 Read our full write-up:
A new direct-to-final final guidance document has been issued regarding reformulating drug products containing carbomers manufactured with benzene, a well-known human carcinogen. 💊 Read our full write-up:
The FDA has updated its guidelines regarding the preparation and submission of reports related to vaccine-related adverse events. Specifically, the FDA's CBER is now employing version 2.3 of the Specifications for Preparing and Submitting Postmarket Individual Case Safety Reports (ICSRs) for Vaccines specification. 💊
The ICH released a new final guideline on the viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. Given that the FDA is a member of the ICH, it is expected to adopt this guideline early in the first quarter of 2024. 💊
The FDA's CBER has published an updated Standard Operating Policy and Procedure (SOPP) that outlines the administrative processes for handling original applications for approval of new biologics and drugs. This updated SOPP includes information on a new policy regarding the consolidation of two applications for the same product. Additionally, it introduces new requirements related to post-market commitments and requirements. 💊
The White House has completed its review of the FDA's Quality Management System Regulation (QMSR) “Consistent without Change.” This clearance suggests that we can expect the final rule to be published at any moment. We shared our thoughts on this on LinkedIn. 💉
The FDA has appointed Elizabeth "EJ" Jungman as its new Chief of Staff. She currently serves as the Director of Regulatory Policy at CDER. The Chief of Staff role is considered one of the most crucial positions at the FDA. While FDA Commissioner Robert Califf is responsible for overseeing the agency and setting its direction, the Chief of Staff plays a pivotal role in ensuring that the agency's operations and initiatives are effectively carried out. 💊
The FDA has granted approval to the first state drug importation program, which was proposed by Florida. The state had been advocating for this approval for several years, aiming to import certain drugs from Canada in accordance with the FDA's final rule on state drug importation plans. But the FDA's approval of Florida's plan comes with specific conditions, including an initial two-year time limit and rigorous testing requirements for the imported drugs. It's expected that the pharma industry may challenge this approval through legal means, potentially delaying Florida's ability to commence drug importation for some time. 💊
Nature Reviews Drug Discovery published its annual overview of FDA drug approvals. In the calendar year 2023, the FDA's CDER gave the green light to 55 new therapeutic products, with 17 of them being biologics. This marks the second-highest number of approvals in the last 30 years. It's worth noting that this number is likely the highest, as the previous high in 1996 was influenced in part by a substantial backlog of applications that was cleared thanks to the newly established PDUFA program at the time. 💊