The Pathway Collaborative Community brings together professionals across multiple industries, to tackle challenges, share expert insights and connect with our global peers. Part of our collaboration has resulted in forming teams to respond as a community and help shape important FDA guidance. If that is something that resonates with you, we would love to have you involved.
Check out the responses below and join the Pathway Collaborative Community today!
-
Description:
A Pathway Collaborative Community response to 𝐅𝐃𝐀 regarding the "𝟒𝟖𝟑 𝐎𝐛𝐬𝐞𝐫𝐯𝐚𝐭𝐢𝐨𝐧𝐬 𝐃𝐫𝐚𝐟𝐭 𝐆𝐮𝐢𝐝𝐚𝐧𝐜𝐞"
Inside the response:
🔹 A practical decision tree designed for everyday use in investigations, mapped against the ICH Q9 Risk diagram- but drives to the “how”. Explore the risk assessment portion here in the attached diagram or access the full decision tree here
🔹 A real-world case study illustrating a holistic approach to addressing observations — submitted with the recommendation that FDA incorporate it directly into the guidance.
🔹 A structured template for deconstructing observations, ensuring every objectionable condition is systematically identified and addressed.
This is the kind of collaborative, industry-driven work that moves the needle. If you are navigating FDA inspections or want tools that support stronger investigations, these resources are worth a look.
Thank you to all the team members for your contributions to our collective response. Team Members Included: William (Al) Kentrup, David McAnany, Steven Niedelman, Marla Phillips, Ph.D.There were additional team members involved who needed to remain anonymous.
-
Description:
The Pathway for Patient Health Collaborative Community (PCC) recently submitted a response to the 𝐅𝐃𝐀’𝘀 “Recommendations on Scale-Up and Postapproval Changes Guidances for Industry: Request for Comments” — and the resources that came out of it are now available for you.
The response team developed a comparative analysis matrix designed to visually identify SUPAC guidance that has been superseded by the ICH Q12 and/or FDA “Changes to an Approved NDA or ANDA” guidances in the following areas:
1. Reporting Categories - site, process, equipment, scale
2. Components & Composition – Quantitative Excipient Thresholds
3. Dissolution / In Vitro Release Testing Protocols
4. Drug / Product -Specific Risk Stratification
5. Manufacturing Equipment Taxonomy
6. Stability Requirements
7. Philosophical Framework (superseded by ICH Q12)
text goes hereTeam Members Included (additional members were required by their companies to remain anonymous):
🔹 Dr. Guillermo Ciudad-Longa DM-IS/T, Global Director Quality and CI (Fmr. Estee Lauder)
🔹 Jeremiah Ohiozeua, Global Director of Quality & Regulatory (Fmr. Medela)
🔹 Marla Phillips, Ph.D, CEO and President (Pathway for Patient Health)
🔹 Giedrė Šinkūnaitė, Validation Lead (Thermo Fisher Scientific)
🔹 Lisa Nolan Wright Wright, Director Regulatory Policy (Novo Nordisk) -
Description: A group of collaborators from the Pathway Collaborative Community came together to dig line-by-line through this draft framework, which guides how AI-enabled medical devices should be managed from design through sunsetting. The result: 60 detailed comments spanning the entire AI product life cycle, including:
🔹 Sharpening patient safety language in the framework's foundational principles
🔹 Aligning explainability and interpretability definitions with the NIST AI Risk Management Framework
🔹 Clarifying risk vs. hazard vs. consequence terminology throughout
🔹 Strengthening guidance on dataset bias, consent, and synthetic data use
🔹 Addressing human oversight, transparency, and manufacturer accountability
🔹 Tackling harder questions like third-party/foundation model dependencies and generative AI monitoring
🔹 Improving clarity on change control, post-market monitoring, and device sunsetting
scription text goes hereTeam behind the submission:
Krishna Appanam, Robin Blankenbaker, Claus Brandorff, Attrayee Chakraborty, MSc, MS, CQSP, Yuzhe Chen, Alex Friedman, Steve Frigon, Elisabeth George, Lacey Harbour Smith MS, RAC, MB(ASCP), Reena H., Michael Iglesias, Ujjwal Jain, Kent Joshi, Mandar Karhade, Shashidhar Malligari , CQSP, Monica Montanez MS RS RAC CQA, Siva Nagireddy Thi Nguyen, Andy O'Connor, Rajha Rajamurthi, Ashkon R., Charles Schlaff, Aarti Shukla, M.S.Rsc, RAC, Rebecca Walters.
There were others who contributed but who wished to remain anonymous.