RA/QA News Roll: Late 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 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.
🚨 Breaking news
The FDA has released the final Quality Management System Regulation (QMSR). Notably, the final rule introduces a two-year phase-in period instead of the initially proposed one-year period. This rule aims to align the FDA's approach to medical device quality system regulations with the international standard ISO 13485, which is already similar to the FDA's existing system and is widely adopted by global regulators. The core aspects of the proposed rule, such as the incorporation of ISO 13485, remain intact. (Talk to us for expert gap assessment and remediation support — qualified consultants are in high demand.) 💉
FDA Guidances and Related Documents
The FDA finalized a guidance document regarding amendments and requests for final approval for tentatively approved generic drugs. This guidance has undergone multiple revisions in recent years, including updates in 2019 and 2020. 💊
The FDA has updated its guidance on revising the labeling of an ANDA after changes to the labeling of an RLD. This new guidance replaces the April 2000 guidance, simplifying the process of keeping generic drug labeling current with the reference drug's approved labeling. 💊
The FDA's CBER has issued final guidance for developing CAR T cell products to aid sponsors in the industry and academia. The guidance covers CMC, pharmacology, toxicology, and clinical study design. It also includes analytical comparability studies advice and applies to other genetically modified lymphocyte products. 💊
The FDA has released draft guidance on remote regulatory assessments (RRAs) to streamline its process for conducting these assessments. The document answers common questions about RRAs and the FDA's methods for conducting them.
The Government Accountability Office has issued a report stating that the FDA recognizes the necessity for additional and updated authorities to effectively regulate medical devices incorporating artificial intelligence. However, the GAO has pointed out that the FDA has not clearly defined, documented, or communicated to Congress the precise legislative amendments required to tackle these challenges. Without this information, Congress might be unable to appropriately enhance the FDA's authorities, potentially causing missed opportunities to fully harness the public health benefits of this technology. 💉
CBER has released its updated guidance agenda. Notably, the list includes only two new guidance documents that were not previously mentioned, with one of them being a draft guidance on Frequently Asked Questions for cell and gene therapy products. 💊
A series of interviews have been conducted with the outgoing Principal Deputy Commissioner, Janey Woodcock, who has had a long-standing career at the agency spanning several decades. These interviews have been featured in various publications, including Pink Sheet, Endpoints, Regulatory Focus, and STAT (some of which may be paywalled).
The FDA has introduced a "Regulatory Science Tools Catalog" to replace its previous webpage. This updated resource enables the industry to conveniently search and filter through the numerous tools recognized by CDRH. However, it currently lacks a feature to indicate which tools are newly added or modified. 💉
CDRH Director Jeff Shuren and CMS's Acting Director of its Center for Clinical Standards and Quality, Dora Hughes, have issued a rare joint statement in defense of their efforts to finalize the Laboratory Developed Test (LDT) rule. The statement aims to underscore CMS's support for the FDA's proposal and emphasizes that CMS views its Clinical Laboratory Improvement Amendments (CLIA) program as having a distinct purpose and scope separate from FDA oversight. Notably, the statement addresses the suggestion that concerns regarding LDTs should be resolved by expanding CLIA, stating, "This is not the answer." It further argues that creating a redundant system for test oversight through CLIA expansion would result in unnecessary government bureaucracy and inconsistencies, which they find unreasonable. 💉
These are the minutes from negotiating meetings between the FDA and the OTC drugs industry regarding reauthorizing the OTC Monograph User Fee Act (OMUFA). The minutes suggest a lack of alignment between the two parties, with the FDA noting that some of the industry's proposals appeared to be beyond the authorized scope of the negotiations. In response, the industry also pointed out that some of the FDA's proposals seemed to be out of scope. Additionally, it's worth noting that the FDA proposes changing the OMUFA facility fee due date from June 1 to October 1 to align it with the start of the fiscal year. 💊
The FDA updated the roadmap outlining the biosimilar research topics that CDER intends to focus on in the upcoming year. The FDA has stated that this document offers more clarity and context regarding selecting research priorities and how advancing these priority areas is expected to influence science-based recommendations and regulatory decision-making within the FDA. 💊
The CDRH has formally implemented its reorganization of the Office of Strategic Partnerships and Technology Innovation (OST), elevating it to "Super Office" status. This reorganization was initially announced in August, and it has now been put into effect as of January 2024. OST is responsible for developing the FDA's regulatory strategies concerning device cybersecurity, digital health, standards, device shortages, and other related matters. The new structure expands the number of offices within OST from three to five, and the office is under the leadership of Suzanne Schwartz, a longstanding member of the office's staff. 💉
The CBER procedures guide, which centers on regulatory meetings with sponsors and applicants of drug and biological products, has been revised. The update involves the removal of an outdated policy related to Wi-Fi connections and the elimination of language pertaining to face-to-face meetings, as indicated in the document. 💊
Reps. Doris Matsui (D-CA) and Larry Bucshon (R-IN) have introduced new legislation called the Mapping America’s Pharmaceutical Supply (MAPS) Act. It aims to tackle drug shortages by instructing HHS to establish a list of essential medicines. It would also require HHS to create a database that maps the pharmaceutical supply chain, including details such as the country of origin, manufacturing quantities, and other important information about critical drug products. This database's purpose is to identify supply chain weaknesses that could lead to shortages or other challenges during future public health emergencies. 💊
The House Energy and Commerce Committee and House Oversight Committee are scheduled to hold a hearing that will specifically address the FDA's Foreign Inspection Program. This decision comes in response to concerns that the FDA has significantly reduced its foreign manufacturing facility inspection efforts, leading to worries about the safety and security of food, drugs, and medical devices manufactured abroad.
Senators Maggie Hassan (D-N.H.) and Mike Braun (R-Ind.) have issued a press release highlighting the reintroduction of their legislation would mandate the FDA to establish regulations necessitating that new medical devices featuring digital displays, such as glucose monitors or insulin pumps, incorporate accessible features for visually impaired users, unless such alterations would fundamentally alter the device's nature. 💉
Compliance and Enforcement
The FDA has placed Indian drug manufacturer Brassica Pharma and U.K. drug manufacturer McCallum Manufacturing on an import alert for all drugs produced at their facilities. This action is specifically related to deficiencies in good manufacturing practices. Typically, such an import alert indicates that both companies will likely receive a Warning Letter from the agency. 💊