RA/QA News Roll: Mid November 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 and 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 Guidances and Related Documents
A new whitepaper from CDER focuses on the distributed manufacturing of drugs. It examines a recent FDA whitepaper on the same topic and summarizes feedback from both the FDA whitepaper and a recent public workshop.
The FDA has released a new guidance document concerning its enforcement policy for "Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions." This guidance was initially published during the Covid-19 pandemic. Now, the FDA is extending this policy, which allows sponsors to implement specific changes to a device designed for rare disease populations without the need for pre-market review before implementing the changes. Instead, the FDA will accept these changes as part of a 30-day notice.
A recently released guidance document outlines an enforcement policy for clinical electronic thermometers. This guidance, much like several others issued recently, is a revised document associated with the Covid-19 pandemic. It's anticipated that a few more of these documents will be made available prior to the FDA's self-imposed deadline of November 7, 2023, for publishing revised guidance. Notably, the FDA has also declared its intention to grant "exemptions from premarket notification requirements" for certain clinical electronic thermometers, subject to specific limitations.
The FDA has released a new final guidance document pertaining to its Real-Time Oncology Review (RTOR) pilot program, which is administered by its Oncology Center of Excellence (OCE). RTOR is designed to expedite the evaluation of oncology products by enabling the OCE to initiate the review process for certain oncology products even before the formal review commencement. This is achieved by allowing the submission of top-line data and other relevant information, and subsequently commencing the official review once the complete dataset is available. This approach can result in FDA reviews that are among the swiftest within the agency, often taking just a few weeks or a short span of months.
The FDA has released a new technical guidance document that provides instructions on how sponsors can submit patient-reported outcome data in cancer clinical trials. It's important to note that this guidance is categorized as Level 2, which means it did not appear in the Federal Register.
The FDA's latest off-label guidance has been posted, and Sidley Austin's FDA practice attorneys have distilled five practical takeaways from it. Among the notable aspects, the revised draft guidance presents recommendations for incorporating various substantive disclosures into scientific information on unapproved use(s) (SIUU) communications. These disclosures encompass information from FDA-approved labeling, such as approved uses, contraindications, or limitations of use. Cumulatively, these recommendations impose a significant burden and may grant the FDA and other stakeholders substantial discretion to scrutinize a company's decisions regarding disclosures and other measures aimed at ensuring the accuracy and non-misleading nature of SIUU communications. This, in turn, could potentially lead to enforcement actions and litigation based on post hoc assessments made by the Department of Justice, whistleblowers, or other parties.
The CDER’s Office of Pharmaceutical Quality (OPQ), a super office charged with evaluating the quality of investigational and marketed drugs and biologics, is being reorganized in January 2024 into a new structure in a bid to address ongoing “pain points,” CDER Director Patrizia Cavazzoni wrote in an email to FDA staff.
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