RA/QA News Roll: Mid February 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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Weβve added emojis to our links to denote pharma/biologic items (π) from device/diagnostic/digital health items (π) when thereβs a clear relevance to only one sector.
Here are some key items from the past couple of weeks.
FDA Guidances and Related Documents
The FDA has recently published several dozen new and revised Product-Specific Guidances (PSGs), which guide prospective generic drug developers on the requirements for specific products' approval. Among these is a new PSG for nasal Naloxone HCl, offering two potential pathways to market: either five in vitro bioequivalence studies or one bioequivalence study with pharmacokinetic endpoints. π
The ICH has revealed a new draft guideline focusing on post-approval safety data management and expedited reporting. Given that the FDA is a founding member of ICH, it is expected that the FDA will release a similar document for public comment shortly after unveiling the ICH guideline. π
The FDA has issued a final guidance on charging for access to investigational drugs in clinical trials. This 14-page guidance document, structured as a Q&A, aims to address common questions regarding the strict requirements set by the FDA regarding this practice. π
Three new documents, dated December 5, 12, and 19, have emerged from recent negotiations between the FDA and the OTC drugs industry concerning the reauthorization of the Over-the-Counter Monograph User Fee program (OMUFA). Meeting minutes indicate that both parties have reached an initial agreement on proposals previously deemed out-of-scope. The December 12 document outlines topics open for discussion, including the use of CDER's NextGen Portal for meeting requests, establishing set timeframes for extending public comment periods and associated OMUFA Goal Dates, maintaining a catalog of historical monograph-related paper documents, and introducing a new meeting type, "Type W," akin to the Type D meetings from the last prescription drug user fee program. π
The fourth revision of the CDER Manual of Policies and Procedures regarding the management of drug shortages has been released. This update, the first since November 2018, aims to incorporate process changes, revise responsibilities, and incorporate new FDA authority granted through the CARES Act of 2020. π
The FDA released a revised draft guidance document on notifying the agency of manufacturing interruptions. (The only noticeable change is that the FDA added a new footnote regarding the submission of comments βat any timeβ to a docket.) π
The FDA has released a final rule aimed at enabling a subset of medicines previously regulated as drugs but now classified as biologics to reference information from the original Drug Master Files (DMFs). This change, initially prompted by Obamacare legislation, primarily impacts insulin products transitioned to biologics licensure. π
FDA General
The FDA's CDRH plans to reclassify most diagnostic products from high-risk (Class III) to moderate-risk devices (Class II). This primarily impacts infectious disease and companion diagnostic tests, potentially easing and reducing the cost of bringing certain companion diagnostics to market. π
The FDA has announced a reorganization of the Office of Digital Transformation (ODT), adding several new offices and divisions within existing offices. Established in September 2021, ODT initially comprised three offices: the Office of Information Management and Technology, the Office of Data, Analytics and Research, and the Office of Information Security. The expanded structure of ODT now includes entirely new offices, such as the Office of Organizational Excellence, and several offices that have been renamed or elevated within their divisions. This reorganization reflects the FDA's ongoing efforts to implement its ambitious Modernization Action Plans (MAPs) and enhance its internal IT systems, which have been a significant concern for both regulators and industry stakeholders.
A new commentary authored by Ryan Robinson and Leonard Sacks from CDER's Office of Medical Policy has been published, focusing on decentralized clinical trials. They discuss the shift towards DCTs, highlighting challenges faced by traditional trial approaches such as burdensome participant requirements. They emphasize the convenience and potential of DCTs, facilitated by advancements in technology and the use of local healthcare providers. The FDA has shown support for DCTs, particularly during the COVID-19 pandemic, and has provided guidance to encourage their adoption while addressing associated challenges and ensuring participant safety. π
The FDA has collaborated with HHS's Administration for Strategic Preparedness and Response (ASPR) to establish an Innovative Technologies and Advanced Manufacturing Hub (I-TEAM Hub). This initiative aims to grant FDA reviewers, scientists, and investigators direct access to cutting-edge analytic and manufacturing technologies, including digitally enabled manufacturing and deployable manufacturing of critical medicines, devices, and medical countermeasures. The I-TEAM Hub also serves to bolster FDA technology modernization efforts and enhance the accessibility of technologies for FDA staff utilization.
Lawmakers criticized the FDA for delays in inspecting foreign drug manufacturers, a backlog of inspections, and vacancies in the foreign inspector workforce. Uninspected foreign facilities pose a risk to the safety of medications relied upon by Americans. The Government Accountability Office raised concerns about the FDA's oversight of the global supply chain and the effectiveness of foreign inspections compared to US inspections. The FDA is addressing these issues, including through an unannounced inspection pilot program in India and China. Alternative inspection tools, such as virtual inspections and reliance on home-country regulators, were criticized for being inadequate. Proposals included employing "preliminary inspectors" and granting the FDA authority for remote inspections using digital technologies. Some lawmakers called for increased FDA funding and authority to enhance its inspection capabilities. Watch our 2021 interview with GAO's Director of Health Care, Mary Denigan-Macauley, on the FDA's inspection backlog: