FDA

The FDA’s latest From a Global Perspective, occasional thought pieces on international topics with experts across the FDA and global public health leaders, is an interview with Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence (OCE). During the interview, he focuses on OCE’s international outreach. Studying cancer drugs overseas enriches FDA’s understanding of these drugs & ensures that treatments are applicable across the U.S. population, he says. Read more: https://lnkd.in/d-kS-qZt

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The FDA has added pediatric ventricular assist bypass devices (product code DSQ) to the Medical Device Shortages List.  Find out more: https://lnkd.in/e79B7ZmE

The FDA is taking action to modernize our regulatory framework by revoking 52 outdated Standards of Identity for food products. This initiative removes unnecessary barriers while maintaining robust consumer protections through modern food safety requirements. Key actions include: • Direct final rule for 11 canned fruit/vegetable standards • Proposed rules for 18 dairy product standards • Proposed rules for 23 additional food product standards This effort supports our commitment to directing resources where they're most needed while fostering innovation in food production. Learn more about how we're streamlining regulations to better serve American families. 

The FDA has released draft guidance addressing a critical challenge in oncology drug development: demonstrating how each component contributes to the overall effect in novel cancer drug combinations. https://lnkd.in/eVYZRruB Key Strategic Implications: 🔬 Factorial Design Preference: The guidance establishes factorial randomized trials as the preferred method for characterizing individual drug contributions, enabling direct comparison against monotherapy arms and standard of care. 📊 External Data Flexibility: When randomized trials are infeasible, external data sources may serve as alternatives, though they require rigorous evaluation of data quality, patient population comparability, and analytical methods. 🎯 Three Development Scenarios: The guidance provides clear recommendations for investigational-investigational combinations, investigational drugs with approved agents for different indications, and combinations of drugs approved for different uses. ⚡ Streamlined Approach: Early and frequent FDA consultation is strongly encouraged, particularly for complex programs, potentially facilitating more efficient development strategies. This guidance, when finalized, will represent a significant step toward more systematic and evidence-based approaches to combination therapy development in oncology, with implications or how pharmaceutical companies structure their clinical programs and regulatory strategies.  Comments are welcome - submission instructions at the link. #FDA #CancerResearch #DrugDevelopment #Oncology #ClinicalTrials #RegulatoryAffairs 

Outsourcing facility and compounding personnel – improve your cleanroom techniques in our Cleanroom course, July 22-24, in Raleigh, N.C. Learn how to conduct cleanroom performance tests, such as airflow velocity and uniformity, HEPA filter leak testing and repairs and airflow visualization smoke studies. FDA, in collaboration with PDA - Parenteral Drug Association, offers practical activities for learning, direct access to industry experts and an opportunity to earn continuing education (CE) credits. Fee: $499. Register at https://lnkd.in/eawAZeWG

🚨 Important Reminder for Medical Device Manufacturers 🚨 Starting Oct. 1, 2025, the FDA will require all De Novo classification requests to be submitted using the electronic Submission Template and Resource (eSTAR). Key points to remember: • Start date: Oct. 1, 2025 • Applies to: All De Novo submissions • Required format: eSTAR Don't wait until the last minute! Start preparing your processes now to ensure a smooth transition. For more information on eSTAR and how to comply with this new requirement, visit: https://lnkd.in/eW5s6yFh

FDA approves first interchangeable rapid-acting insulin medication. Kirsty (insulin aspart-xjhz) is an interchangeable biosimilar to Novolog (insulin aspart). An interchangeable biosimilar may be substituted at the pharmacy for the reference product, depending on state laws. For more information about biosimilars and interchangeable biosimilars, visit www.fda.gov/biosimilars and also read “9 Things to Know About Biosimilars and Interchangeable Biosimilars”:https://lnkd.in/ecZCNfZr

Today, we announced the issuance of seven warning letters to companies illegally marketing products containing 7-hydroxymitragynine (7-OH). https://lnkd.in/eEthYBXj While 7-OH is naturally present in kratom in trace amounts, the Agency is particularly concerned about concentrated, potentially dangerous products—such as tablets, gummies, drink mixes, and shots—being sold online and in smoke shops, gas stations, and corner stores. This action underscores the Agency’s increasing concern over these novel potent opioid products.

The FDA has updated its list of medical devices that incorporate augmented reality and virtual reality (AR/VR). https://lnkd.in/e973BD25 This list is a resource intended to identify AR/VR medical devices that are authorized for marketing in the U.S.