RA/QA News Roll: Late March 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.
FDA Guidances, Regulations, and Related Documents
The FDA has finally released a long-awaited proposed rule outlining which drug products and categories it considers challenging for compounding. The FDA will assess various criteria, such as complex formulations, drug delivery methods, dosage forms, bioavailability, compounding processes, and testing processes, to determine which products fall into this category. Additionally, the FDA plans to include three new categories of drugs on its list of those difficult to compound: oral solid modified-release drug products with coated systems (MRCs), liposome drug products (LDPs), and drug products made using hot melt extrusion (HMEs). 💊
The FDA has released a new final guidance document addressing the handling and retaining of bioequivalence and bioavailability testing samples. These tests are crucial for determining the similarity of a drug to a reference product, which is essential for generic drug development and comparability testing after manufacturing changes. The samples used in these tests are vital for regulators to access for auditing and assurance purposes. According to current regulations, reserve samples must be stored for at least five years. The guidance specifies that an independent third party should select and manage these samples. 💊
The FDA has released a new draft guidance document concerning the design and analysis of pharmacokinetics (PK) in patients with impaired renal function. PK involves studying and assessing how the human body processes a pharmaceutical substance. In patients with decreased kidney function, drugs might not be efficiently eliminated from the body, or they may exhibit differences in absorption, metabolism, and transportation. 💊
The FDA has recently issued a new informal Q&A guidance aimed at providing additional information to sponsors interested in participating in CDER's Voluntary Quality Management Maturity (QMM) Prototype Assessment Protocol Evaluation Program, which began accepting volunteers in January. The QMM concept essentially serves as a measure of heightened levels of drug quality, for which the FDA may potentially offer rewards to companies. 💊
A new set of industry comments has been submitted regarding the FDA's draft guidance document on using master protocols during drug development. Master protocols represent a non-traditional trial design aimed at enhancing the speed and efficiency of development. They enable one product to be studied against multiple disease targets or facilitate testing numerous drug candidates against a single disease with just one control group. 💊
FDA General
The FDA has set user fee rates for OTC monograph facilities for FY2024. The new fee amounts to $34,166 for monograph drug facilities and $22,777 for contract manufacturing organization facilities. This marks a notable increase compared to the previous year, when facility fees were set at $26,153 and $17,435, respectively. 💊
The FDA is developing a Risk Evaluation and Mitigation Strategy (REMS) "integration pilot" program. The aim is to address the cumbersome manual data exchange among stakeholders in current REMS systems. To streamline REMS programs, the FDA plans to initiate a "real-world pilot" and further refine and test the automation of REMS routing. 💊