#FDA just posted a new draft guidance for platform technology designations. This has been a big topic of conversation in #biomanufacturing and #AdvancedManufacturing for a while. Do you think this will increase adoption of new manufacturing technologies? Does it strike a good balance? Let FDA know by commenting on the docket by July 29!
Wonderful progress on this! I have some fun and highly productive reading ahead of me. Thanks to all who put this together.
Check out our experts’ thoughts on platform technology
ELIQUENT Experts, Michele Dougherty and Steven Bowen Ph.D. examine the FDA's highly anticipated guidance on Platform Technology Designation Program, which provides insight into the Agency’s current thinking on platform technology in drug development, manufacturing and streamlining the review process. Read their analysis at https://lnkd.in/e-nDtRkP
Advanced Manufacturing Guidance Needs Detail on Benefits, Comments Say: The FDA’s draft guidance on its Advanced Manufacturing Technologies (AMT) program is a great start for encouraging industry to develop these systems but it needs a lot more detail before businesses will wholeheartedly embrace it, according to stakeholder comments. #fda #financial #lifesciences
Drugmakers have been slow to adopt the production process, which experts say can streamline operations, boost data quality and reduce time to market. Read more about the underlying reasons in this article on Manufacturing Dive https://lnkd.in/eqr2E7KZ
Principal Consultant & President FRAPS, FAAO Design Excellence/Procees Excellence Blackbelt Design Thinking SME
Important read. Interesting particularly at the tail end of the draft guidance, wherein it indicates drug delivery devices most likely will not meet the requirements to be considered platform technologies. That doesn’t mean pre-existing data cannot be appropriately leveraged, but it means they aren’t treated as platform technology. #combinationproducts #drugdelivery #platformtechnologydesignation
Resilience going from strength to strength, this is great to see. https://lnkd.in/eUGZ_GSC
National Resilience Inc. is expanding capabilities at its #RTP facility, using modular design in its expansion space to offer drug product manufacturing for multiple modalities. Learn more at: https://hubs.ly/Q02mdGVD0
Unlock the potential of your drug product program with DSI's expert consultants. From navigating scale-up challenges to optimizing production processes, we're here to streamline your journey. Explore our comprehensive drug product services: https://bit.ly/3QYcM2g #DrugProduct #Consulting #ScaleUp #Production #Manufacturing #DSI
Decoding Pharma Serialization: Swipe through our carousel to uncover the intricate standards and prevailing challenges shaping the industry! 🧩 Read full article here: https://lnkd.in/dJeZ2KVk 💊 From compliance hurdles to technological advancements, explore the full spectrum of serialization. Ready to tackle these challenges head-on? Dive into the full post now! 🚀 #PharmaSerialization #IndustryStandards #ComplianceChallenges #TechAdvancements #TheWolfPractice #CarouselInsights #PharmaSolutions #StayAhead
The pharma industry has been calling for a standardized approach on how companies and regulators communicate. Automation can be one of the solutions. It ensures consistency of content and increases the quality of conversations among stakeholders. For the full article, click here: bit.ly/4btBSOY
Have you seen this technical brief from Vice President of Lab Services, Kaitlin Lerner? Read to explore: ⚗️ 4 key pain points of in-house chemical characterization ⚗️ How outsourcing can accelerate your product development ⚗️ The critical role of expertise in ensuring regulatory compliance #MedTech #ChemicalCharacterization #RegulatoryCompliance
𝗔𝗿𝗲 𝗶𝗻-𝗵𝗼𝘂𝘀𝗲 𝘁𝗲𝘀𝘁𝗶𝗻𝗴 𝗰𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀 𝗵𝗼𝗹𝗱𝗶𝗻𝗴 𝗯𝗮𝗰𝗸 𝘆𝗼𝘂𝗿 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲 𝗼𝗿 𝗽𝗵𝗮𝗿𝗺𝗮 𝗱𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁? This blog by Kaitlin Lerner of Jordi Labs explores: ⚗️ 4 key pain points of in-house chemical characterization ⚗️ How outsourcing can accelerate your product development ⚗️ The critical role of expertise in ensuring regulatory compliance Discover how partnering with specialized lab services can drive innovation and success in your projects. Read the full article to learn how you can enhance product safety, reduce costs, and navigate complex regulatory requirements: https://lnkd.in/gp_Bm82A #ChemicalCharacterization #LifeSciences #RegulatoryCompliance #LabServices #MedTech
Biosimilars have been a hot topic, but are we missing the bigger picture? A new article by Dr. Sarfaraz Niazi explores the irrationality surrounding biosimilars, suggesting regulatory changes and manufacturing tweaks could make them as affordable as generics! https://lnkd.in/e7iNWZZy
Innovative, Strategic Business & Operations Leader I Founder I Management Consultant
6moLikewise, it'll be some light reading for a lovely Sunday :-)