RA/QA News Roll: Mid June 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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Here are some key items from the past couple of weeks.

💊 = Pharma, biologic, and biotech.
💉 = Medical device, medtech, and diagnostics.

FDA Guidances, Regulations, and Related Documents

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• The FDA's latest report on the State of Pharmaceutical Quality in 2024 provides several intriguing insights. Highlights include the addition of 227 FDA-registered manufacturing sites in the U.S. and 120 in China. Inspections for drug quality increased from 548 in FY2022 to 776 in FY2023. The report also notes significant strides in foreign inspections, with 25% of all Indian sites inspected compared to 6% of Chinese sites. Additionally, it features a new risk map detailing critical manufacturing site assessments and more. 💊 Read our analysis:
  

  7 Key Takeaways From FDA's FY2023 Report on the State of Pharmaceutical Quality

• The FDA recently released two draft guidance documents on bioresearch monitoring (BIMO) inspections, which cover inspections of both human and animal studies. The first guidance focuses on the submission of information used for planning and conducting BIMO inspections, while the second guidance outlines the processes and practices relevant to these inspections. 💊

• In a recent whitepaper, the Association for Accessible Medicines (AAM) urged the FDA to simplify its regulatory requirements for biosimilars. The paper argues that comparative efficacy studies and three-way pharmacokinetic comparisons are often unnecessary and should not be routinely required. Instead, AAM proposes that the FDA should have the option to request these studies on a case-by-case basis. The paper also calls for the FDA to collaborate with other regulatory authorities to establish global comparators, which would eliminate the need for repetitive pharmacokinetic testing of reference products from different regions worldwide. 💊

• According to a recent report by the U.S. Pharmacopoeia, 2023 witnessed the highest number of drug shortages in the past decade. The report highlights that few new shortages were resolved during this period, with average durations exceeding 1,200 days and some lasting more than a decade. Injectable drugs appear to be particularly affected by these shortages. 💊

• A newly revised CBER Standard Operating Policies and Procedure (SOPP) now centers on the posting and announcement protocols for Premarket Approval Application and Humanitarian Device Exemption approvals and denials. Notably, CBER has eliminated the previous requirement for its staff to post approvals in the federal docket. 💉

• The FDA has released a new final guidance document on clinical pharmacology considerations for the development of oligonucleotide therapeutics. 💊

• The FDA has issued a new final guidance document on developing drugs specifically for the treatment of diabetic foot infections. 💊

• In a new FDA report examining drug shortages experienced in 2023, there is a notable absence of mention regarding active and ongoing shortages. This contrasts sharply with a recent report from USP, which highlighted that drug shortages were at record highs during the same period. 💊

• Here’s the slide deck from CDRH's recently meeting on draft guidances regarding enforcement policies for IVDs offered during public health emergencies. 💉

• The FDA has published a new question-and-answer guidance document related to the ICH M10 guideline on bioanalytical method validation and study sample analysis. 💊

FDA General

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• CDER has launched a new Emerging Drug Safety Technology Program (EDSTP) aimed at harnessing artificial intelligence and other advanced technologies to enhance drug safety monitoring (pharmacovigilance). The initiative includes the introduction of a new meeting format designed to support participants in their pharmacovigilance endeavors. 💊

• During an ASCO session, FDA Commissioner Robert Califf addressed the persistent issue of drug shortages in oncology, discussing potential solutions to this long-standing problem. The recording is available on X (Twitter). 💊

• In a recent podcast, M. Khair Elzarrad, Director of CDER's Office of Medical Policy, discussed the potential applications of artificial intelligence in clinical trial design and research. 💊

• The FDA issued a significant response to a Citizen Petition from Nautilus Gloves, the sponsor of a nitrile exam glove product. The FDA had previously removed the product from the market after discovering that the company's In Vitro Cytotoxicity testing, conducted by a Chinese testing laboratory, Shenzen Boyuan Testing Technology, was likely duplicated from a prior submission. Nautilus petitioned the FDA to reconsider its decision, initially denying the submission of duplicate data before acknowledging that the laboratory had "inadvertently" submitted another company's data to Nautilus. The FDA ultimately rescinded clearance, and the company appealed, claiming the mistake was "clerical." However, the FDA strongly rejected the appeal, stating, "It is in the interest of the public that 510(k) submissions for devices contain valid and accurate data and that FDA uphold such requirements [...]. As such, FDA believes Nautilus will not be able to show that staying the rescission of K210496 510(k) is outweighed by the public health or public interests." 💉

• The FDA released an updated Medical Device User Fee Act (MDUFA) quarterly performance report, covering the second quarter of the 2024 fiscal year, ending March 31. 💉

• Following an FDA advisory committee meeting on Lykos Therapeutics' MDMA therapy for PTSD, the committee decisively voted against the product's efficacy and safety. The meeting, marked by a lengthy and sometimes startling discussion, highlighted concerns about trial design flaws, ethical breaches, patient risks, and even allegations of sexual misconduct. 💊

• In a new FDA blog post authored by Emer Cooke, head of the European Medicines Agency (EMA), the collaboration between the FDA and EMA is discussed. 💊 💉

• According to a report, the FDA's priority to finalize its New Dietary Ingredient Notification (NDIN) guidance documents has taken precedence over efforts to require companies with new dietary ingredients to notify the FDA and undergo a safety review. This delay has persisted despite nearly a decade of ongoing work on the guidance documents. 💊

• In a press release, it was announced that the FDA has entered into an agreement with CluePoints, enabling the agency to continue utilizing a software-generated "ranked list of anomalous [clinical trial] sites" to aid in prioritizing site inspections for FDA inspectors. 💊

• A recent "Ask me Anything" thread on Reddit featured Sarah Yim, the FDA's top biosimilars official. The discussion includes notable insights, such as the FDA's openness to reconsidering the four-letter naming convention for biosimilar and biologic products. 💊