Melodie Bryce

Good overview of upcoming key FDA decisions.

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Have a non-novel CDx need and thinking about how FDA CDx reclassification and FDA Final LDT rule might impact your US CDx strategy? Reach out to Boudicca Dx-we are here to support all your US CDx needs in this changing regulatory landscape!

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July is Disability Pride Month and has been celebrated for almost 30 years to mark the anniversary of the Americans with Disabilities Act (ADA) which was passed on July 26, 1990. Admittedly, I have not been aware of Disability Pride month until a couple years ago but cherish the idea of celebrating and empowering people with disabilities to take pride in who they are. This pride in conjunction with one's disability identity does not always come easy especially in a world not built for us. Requesting accommodations or special services so we can execute basic tasks is often filled with shame. It triggers feelings of being a burden, not worthy the effort or just feeling 'less than'. It is during those low moments that we shall remember and take pride in our uniqueness, our inherent problem solving skills and innovative thinking and most importantly the gives ability to see the world through a unique and valuable lens! Check out the spotlight article below to also learn more about the Disability Pride Flag and the meaning of the different colors! Here is how you can help celebrate: 1. Listen - Don't assume! 2. Learn - Be an advocate! 3. Love - Help remove the stigma! Happy Disability Pride Month! #disabilitypride #inclusion #diversity #advocacy https://lnkd.in/gzaS7wVk

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Last month, the #FDA released the much-anticipated #draftguidance, Platform Technology Designation Program for Drug Development. In her article for Cell & Gene, former FDA / #CBER regulatory Kimberly Benton, Ph.D. answers some of the questions you may have about how this guidance impacts #cellandgenetherapy products and the technologies used in their manufacture. https://lnkd.in/erAKFPfb

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Checkout this video for out initial thoughts on the final rule for LDTs.

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In this month's Newsletter, Kristin Owens and Marianne Doherty share The NemetzGroup LLC's experience with launch planning and the important role of governance in ensuring success. This is a longer newsletter but worthy of your time, especially if you are in launch planning mode! Enjoy #nemetzgroup #launchplanning #commercialization

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TMF Tips for Success Here are some golden nuggets: 1. Regulatory Guru Status: Stay sharp on ICH-GCP, FDA, and EMA guidelines. They’re not just rules; they’re your playbook! 📚 2.Document Lifecycler: Manage those documents like a pro gardener. Plant, nurture, and watch them flourish from draft to archive. 🌱 3.Communication Maestro: Keep everyone in the loop. Clear, concise, and continuous communication is your symphony. 📲 Working in the TMF isn't a Job, but an art form. Share your tips and experiences below! Learn more here: https://lnkd.in/gUMU2-xm * * * #TrialMasterFile #ClinicalResearch #LifeSciences

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FDA'S NEW BIOSIMILAR GUIDANCE The FDA's updated guidance eliminates the need for switching studies for biosimilar interchangeability, emphasizing the importance of robust analytical and clinical data. This shift accelerates biosimilar approvals while maintaining safety and efficacy At QxP, we provide unparalleled expertise in interpreting these evolving regulatory requirements, ensuring compliance and expediting your product's journey to market. Learn how our comprehensive consulting services can support your biosimilar development. https://lnkd.in/eUE4erAt #pharma #biotech #qualityassurance #biosimilars

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Curious about how the FDA's guidance on Benefit-Risk Assessment for New Drug and Biologic Products impacts your development program? Read our blog here: https://lnkd.in/enfY73V9

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We Are GMP Pros, Inc.® Our approach is different. We lead change from the inside out with a team of technical experts and savvy strategists who know how to navigate FDA-regulated manufacturing. We work person-to-person with your team to offer immediate support, while also building the structures to support long-term change. #manufacturing #fda #engineering #biotechnology #pharma #animalhealth #food

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BDRA Consulting LLC has been a member of AMDM since 2013. Come join AMDM for the entire story. Twice a year, members get to meet with the FDA to discuss upcoming regulatory and quality policies. The FDA provides industry updates. This year's meeting was held at Building 66, White Oak campus on May 21, 2024. Key Takeaways from the May 2024 AMDM Industry FDA Roundtable: 1. Cybersecurity for medical devices is a key issue. OHT7 and CDRH have increased focus on cybersecurity for medical devices. 2. The Oncology Diagnostic Pilot Program is nearly a year old, and no company has been accepted. This is primarily because drug manufacturers have not been able to provide validation data. 3. Reclassification plans for companion diagnostics are ongoing and will be completed by November 2027. - FDA is considering down-classifying three types of CDxʼs: i. Nucleic acid-based CDX ii. In situ hybridization-based CDX iii. Immuno-histochemistry-based CDX - Technologies will be grouped based on the intended use. 4. PCCP guidance for medical devices will be published before the end of the fiscal year 2024. A PCCP may be used to make changes to sample type changes, which may be acceptable in certain cases. 5. QSIT is being replaced by an entirely novel risk-based approach, which is currently being worked out. Manufacturers should be working through transition plans. #AMDM

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Hello Health Authority Regulated peeps!! Is anyone looking to build or improve their SOP writing?? If so, please consider having Pamela Hurley help you with your journey! Check out the catalog for more solution HW Products offers! Contact Pam Hurley for more!

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The FDA's Final LDTs Rule: What You Need to Know! 🚨 Curious about the key changes in the FDA's final laboratory-developed tests (LDTs) rule vs the proposed version? Get insights from Julie Ballard as she shares her expert opinions with Rachel (Muenz) Vachon. Discover how these updates can impact your laboratory and what steps to take next. 💡 Don't miss out on this essential read here: https://lnkd.in/e-cgZJMg Click the link and join the conversation in the comments. #HealthcareInsights #LabTesting #FDAUpdates

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Post-marketing commitments play a pivotal role in further evaluating the safety and efficacy of approved drugs by requiring additional studies or surveillance beyond initial approval. The FDA has been intensifying its efforts to ensure companies fulfill their post-marketing obligations, signaling a heightened focus on compliance and transparency. This is evidenced by guidances such as the recently released REMS Logic Model which offers a clear framework for effectively and iteratively conducting a REMS assessment, a process that was not previously well defined. Industry should expect to see additional guidance that supports more stringent post-marketing surveillance. CRC is committed to understanding these changes to ensure our clients maintain regulatory compliance throughout their products' lifecycle. #FDA #REMS #RegulatoryCompliance #Biotech #DrugSafety #Innovation #PatientCare #Consulting 

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And the legal challenges for FDAs final rule on LDTs begin. https://lnkd.in/epzEUN-Q

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Labcorp is buying up more than it planned. Adam Schechter (CEO) says they have a lab purchase that pays for itself in a year. That's an insane return on investment. Labs now are complaining about the dire situation and lack of money. Kinda a miracle: a lab in an awful situation comes to LabCorp, and suddenly feels so much better that it pays for itself in a year. The reasons? Effective management, of course. And what are the alternative ways to better management? A good LIMS, of course. https://lnkd.in/d5AM_3uJ. #LabCorp #acquisitions #HealthcareIndustry #laboratoryServices #LIMS #VivicaLIMS #LifeDataLab https://about.vivica.us https://lifedl.net

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