RA/QA News Roll: Mid April 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

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• The FDA has released a new draft guidance document regarding data integrity considerations for bioavailability and bioequivalence (BA/BE) studies, which are commonly used in generic drug development to prove that a generic drug is equivalent to a reference product. The FDA's thrust with this guidance: making sure these studies are conducted to instill trust in the data among regulators and prevent potential data integrity problems. 💊

• The FDA recently issued a product-specific guidance document concerning Oxymetazoline Hydrochloride. This document offers a suggested testing protocol for potential generic versions of nasal spray products such as Mucinex and Afrin. 💊

• The FDA has released a new guidance document focusing on New Dietary Ingredient Notification (NDIN) Master Files for dietary supplements. NDINs are utilized by companies to inform the FDA of their intention to market a dietary supplement that has not previously been legally marketed in the U.S. These notifications contain pertinent information regarding the ingredient's history, usage, and safety. In this context, a Master File serves as a document allowing one sponsor to reference proprietary information owned by another company that owns the Master File. For instance, if Company A's product relies on an ingredient produced by Company B, and Company B prefers to keep the manufacturing process confidential, a Master File could be submitted. This allows the FDA to ensure that the ingredient used in Company A's product complies with FDA regulations without disclosing proprietary details to Company A. 💊

FDA General

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• The FDA has announced the selection of the first 9 participants to join its Quality Management Maturity Program. 💊

• The FDA has announced its intention to host the Fifth Online Controlled Substances Summit on July 25-26. 💊

• The FDA identified a new set of drug-related safety signals using its FDA Adverse Event Reporting System (FAERS) from October to December 2023. 💊

• The Alliance for a Stronger FDA is hosting a series of presentations featuring key FDA staff members. Participants will include:

  • CDER Director Patrizia Cavazzoni

  • CBER Director Peter Marks

  • CDRH Director Jeff Shuren

  • ORA Associate Commissioner for Regulatory Affairs Michael Rogers

• HHS unveiled its latest plan through a white paper, which aims to encourage hospitals to adopt good purchasing practices to prevent shortages of drugs. Additionally, the plan references the FDA's Quality Management Maturity efforts, suggesting that it could be utilized to establish metrics regarding adopting manufacturing practices that improve supply chain resilience. Purchasers, providers, and consumers could then use these metrics to make informed purchasing decisions. 💊

• Recent data indicates a significant uptick in the pace of FDA novel drug approvals. So far in the 2024 calendar year, the FDA has approved a total of 11 New Molecular Entities. 8 of these approvals occurred on or after March 13, indicating a notable acceleration in the approval rate in recent weeks. 💊

• CDER's Office of Pharmaceutical Quality has released its annual report, summarizing its activities throughout 2023, including key data highlights. 💊

• In an FDA interview with Gerald Dal Pan, Director of CDER’s Office of Surveillance and Epidemiology (OSE), the focus was on the agency's postmarket surveillance practices. One notable observation highlighted in the interview is the FDA Sentinel Innovation Center (IC) using machine learning and natural language processing technologies to enhance the accessibility and integration of data from clinical narratives for safety studies. 💊

• The FDA has completed work on its highly anticipated Diversity Action Plan guidance and has recently submitted it to the White House.

• MedTech Dive has published a comprehensive report delving into the FDA's approach to cybersecurity for medical devices. 💉

• The FDA is currently accepting nominations from industry organizations for its Device Good Manufacturing Practice Advisory Committee. Nominations for voting members to serve on its Patient Engagement Advisory Committee are also being requested. 💉

• The FDA has announced that it will host a public meeting on financial transparency and the effectiveness of its drug and biologics user fee programs. 💊

• The FDA has released a new annual compilation of notices concerning susceptibility test interpretative criteria. These webpages aim to identify which bacteria or fungi are susceptible to particular antibiotics or antifungals. The goal is to minimize inappropriate prescribing and mitigate the rising rates of antimicrobial resistance to existing antibiotics. 💊

Governing

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• Rep. David Schweikert (R-Ariz.) has introduced a bill suggesting that vaccines targeting opioid, fentanyl, cocaine, methamphetamine, and alcohol use disorders could qualify for FDA breakthrough therapy designation, priority review, and Fast Track status. The initial product approved under this proposal could also receive a "Vaccine X-Prize" valued at one billion dollars. 💊