RA/QA News Roll: Late May 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.

Some big news first: The proposed reorganization of many of the FDA's regulatory functions, including its Human Foods Program and Office of Regulatory Affairs, has received official approval from HHS.

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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.

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Here are some key items from the past couple of weeks.

FDA Guidances, Regulations, and Related Documents

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• The FDA has unveiled its much-anticipated draft guidance document on the Platform Technology Designation Program for Drug Development. This 18-page draft guidance provides insights into how product sponsors can utilize an existing platform to streamline and accelerate additional product approvals. 💊

• The FDA issued a final regulation concerning the administrative destruction of medical devices suspected to be counterfeit and valued at less than $2,500. The rule aims to strengthen efforts to prevent counterfeit medical devices from entering the U.S. by minimizing opportunities for counterfeiters to re-import the same device after it has been seized by U.S. Customs officials. 💉

• On May 20, the FDA’s new advertising regulation regarding clear, conspicuous, and neutral statements in direct-to-consumer (DTC) drug advertising went into effect. Initially, it's optional from May 20 onwards, but it becomes mandatory as of November 20, 2024. The FDA scheduled a meeting on the rule and how to promote products for June 26, 2024. 💊

• FDA has released a new report examining its generic drug science and research conducted during Fiscal Year 2023 under the Generic Drug User Fee (GDUFA) program. 💊

• The ICH has released a draft of its M14 guideline, titled "General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines." As a member of the ICH, the FDA is involved in this initiative. Typically, the FDA releases ICH documents for consultation within two months of their release by the ICH. 💊

• The ICH recently finalized its M12 guideline on "Drug Interaction Studies," along with an associated Q&A guideline. The FDA is expected to publish and adopt this document within a few weeks. 💊

• A new AAMI standard aims to assist manufacturers in adhering to the FDA's regulation on CGMPs for combination products. 💊 💉

FDA General

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• The FDA has updated its recognized medical device standards database to include 61 new and updated standards. This update encompasses various areas, such as medical device sterility, device software, device materials, and specific therapeutic domains. 💉

• A recently announced meeting will examine the evaluation of immunosuppressive effects resulting from in-utero exposure to drugs and biological products. As the FDA states, the aim of this public workshop is to address the transplacental transfer of drugs and biological products possessing immunosuppressive properties and their potential clinical ramifications on the developing fetus and newborn infant. The agenda includes discussions on identifying knowledge gaps, exploring innovative data collection methods, and fostering a deeper understanding of the subject matter. 💊

• The FDA has issued a new order to reschedule ultrasound cyclodestructive devices, now classifying them as Class II with special controls. 💉

• The FDA's Oncology Center of Excellence has announced the launch of the OCE Equity Program, an extension of its existing Project Equity. Nicole Gormley and Tamy Kim will serve as co-directors of the program. According to a statement from OCE, the Equity Program aims to further the center's efforts to enhance access to clinical trials of oncology medical products for historically underrepresented populations in clinical research. Additionally, the program will encompass OCE's Project ASIATICA and Project Silver. 💊

• At the recent FDLI conference, CDER Director Patrizia Cavazzoni made it clear that there are no plans to extend the enforcement delay for manufacturers' track and trace verification systems under the Drug Supply Chain Security Act (DSCSA). She expects these systems to be operational by this November. Although the requirements officially took effect in November 2023, the FDA had postponed enforcement for one year to grant companies additional time for compliance. 💊