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Join Snehal Patel and the team at Sana Biotechnology, Inc. as they utilize engineered cells to create groundbreaking medicines for patients. Learn…
Join Snehal Patel and the team at Sana Biotechnology, Inc. as they utilize engineered cells to create groundbreaking medicines for patients. Learn…
Liked by Diane Hagerty
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I am honored and humbled to be recognized as one of this year's Top 10 HR Professionals by OnCon Icon Awards. I am deeply grateful to my colleagues…
I am honored and humbled to be recognized as one of this year's Top 10 HR Professionals by OnCon Icon Awards. I am deeply grateful to my colleagues…
Liked by Diane Hagerty
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Margot Borgel, Ph.D.
Very excited to be presenting this webinar on FDA’s Final Rule for Laboratory Developed Tests for RQM+. When: June 20, 2024 @ 11:00AM EST Register here: https://lnkd.in/ebfw66B2 There have been a LOT of LDT webinars in the last few weeks, but I promise this one is different. We will not just be regurgitating the rule. Instead, Bethany Knorr Chung, PhD, RAC and I will be giving you strategies and tips for execution. Do you have questions? Drop them in comments or my messages before the the webinar, or bring them along the day of.
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AAMI
The 2026 deadline for compliance with FDA's new QMSR is closer than you think! At this year’s AAMI-FDA neXus, we heard from CDRH Director Jeff Shuren and other FDA experts about the rule, and what’s next for medical device manufacturers. #Medicaldevices #FDA #RegulatoryCompliance https://lnkd.in/ecuSzq4Y
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Shree Koushik PhD RAC
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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G&L Healthcare Advisors
From GCP and GMP to inspection readiness and remediation issues, our expert QA teams work with companies of all sizes and development stages to support all aspects of clinical and commercial quality across the entire product lifecycle. Samantha Taylor CMgr MCMI, Assistant Vice President of Business Development, is ready to tell you more about how our phase-appropriate, scalable QA support can help you mitigate risk and guarantee compliance. You can book a chat with her here: https://lnkd.in/e6HiZ5ac #HealthcareAdvisors #QualityAssurance #RegulatoryAffairs #RegulatorySupport
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1 Comment -
Mara Aspinall
This week, the FDA released its long-awaited final rule on the regulation of laboratory-developed tests (LDTs). #sensitiveandspecific #specialreport #FDA #laboratorydevelopedtests #LDT #infectiousdisease #publichealth #publichealthemergency #diagnostics #diagnostictesting #FDArule #FoodandDrugAdministration
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Karin Hoelzer
A unique opportunity for #raredisease advocates and those who serve our community including #diagnosticlaboratories that design and offer #labdeveloped tests #LDTs and that with the newly finalized FDA #LDT rule will have to comply with #device #regulations for #invitrodiagnostics #IVDs. (Almost) everything you ever wanted to know about #regulatoryaffairs for #prescriptiondrugs, #biologics, and #medicaldevices, wrapped up in one neat two-day conference, and participation is FREE! Join FDA *May 29 and 30th* either in-person or remotely, and learn about #clinicaltrial #innovation, the use of #AI #artificialintelligence in #drugdevelopment, #combinationproducts, the #510(k) process, quality management systems #QMS, the development of #genetherapies for rare diseases, best practices for #patientengagement, and so much more. Go here to learn more and register: https://lnkd.in/eEc9XWbD
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EMMA International
#FeaturedBlog Today's feature discusses The FDA phase out of the LDT Enforcement Discretion. The FDA has outlined a phased approach to implementing a new regulatory framework for LDTs. This approach is designed to provide laboratories with sufficient time to adjust to the new requirements while minimizing disruption to patient care. Laboratories will be expected to gradually transition their LDTs to comply with FDA regulations, with priority given to tests that pose the greatest risk to patients. Read more here: https://lnkd.in/enhtD7XM
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Michael Yartzoff MS, MBA, DRSc
A thought provoking article on the health risks of formaldehyde. An industrial chemical used widely for decades. As is with many other similar types of chemicals, we learn more about safety profiles over time. What was considered safe 50 years ago, is looked at in today’s world using a wealth of historical information. We may find, what was previously thought safe is now understood to be a risk, or in other cases, we may find a lower risk. This article highlights meaningful work by the EPA, and all of the dedicated staff, to create a safer society going forward, and applying a risk based approach to evaluate chemicals used widely in our world.
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Jose Caraballo
FDA plans to release AI drug development guidelines. Key takeaways: The FDA is set to revolutionize drug development with its forthcoming draft guidance on utilizing AI/ML, marking a pivotal moment in regulatory history. The exponential rise in AI-driven submissions, from just one in 2016 to a staggering 128 by 2021, underscores the pharmaceutical industry's rapid adoption of cutting-edge technology. AI's multifaceted role spans every phase of drug development, promising to streamline processes and enhance outcomes. With over 800 comments received, FDA's commitment to incorporating stakeholder feedback ensures a collaborative approach in shaping robust regulatory frameworks for AI integration. Alongside the guidance, FDA's initiatives to establish best practices and uniform terminologies signal a proactive stance towards harnessing AI's full potential while fostering transparency and global harmonization.
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Hyman, Phelps & McNamara, P.C.
Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA “inspection.” In an effort to clarify for industry and alleviate some of the stress associated with these activities, last week the FDA issued a draft guidance aimed at providing recommendations on how to handle inspections under FDA’s Bioresearch Monitoring (BIMO) program. In a recent blog post Anne Walsh and Sarah Wicks highlight FDA’s views about best practices for BIMO inspection communications, handling requests for records, and inspection preparation and follow-up as outlined in the draft guidance. Read the blog post here: https://lnkd.in/dJHUbR5P #fda #fdalawblog #cGMP
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PHARMeMED
There is a need for the scientific community to explore the use of additional strength biowaivers for modified release (MR) drugs given the increasing market demand for these “patient centric” products, said Robert Lionberger, director of the US Food and Drug Administration’s (FDA) Office of Research and Standards in the Office of Generic Drugs. Lionberger made these remarks at the 18 April FDA/PQRI workshop on challenges and opportunities for modified release oral drug product development. He said this work should be conducted as part of efforts to establish a global harmonized framework for bioequivalence (BE) testing for MR products. “We are close to wrapping up the M13 harmonization for immediate-release (IR) products so logically the thing that come after immediate release is modified release,” Lionberger said. He added that “it is important to not just to look at a global framework but a more scientifically sound framework.” Earlier in the week, FDA officials announced that ICH M13A guideline, which sets a harmonized framework for assessing BE for IR drugs, is set to be adopted this summer. (RELATED: ICH M13A BE testing guideline expected to be adopted this summer, Regulatory Focus 17 April 2024) Currently, FDA does not waive BE studies for additional strengths of MR products. Rather, FDA makes a determination about BE for each MR strength based on in vitro data. Generic drugmakers can file suitability petitions if there is a market need for different strengths of a MR product. Biowaivers can also be granted if sponsors can establish an In Vivo/In Vitro Correlation (IVIVC) between the test and reference drug. FDA’s revised guidance on BE testing issued in August 2021 sets out limited conditions for which it will make a determination of BE for each MR strength based on in vitro data. One of these conditions state that “the test product includes the same excipients for different strengths and the ratios of drug and excipients among different strengths of the test product is justified and appropriate for the drug release mechanism of the test product (e.g., drug and excipients of different strengths can be either proportional or not proportional in quantity).” Read more: https://lnkd.in/eKgRtXiz Articles/2024/4/FDA-official-Biowaiver-framework-needed-for-modifi Stay in touch with all the leading stories, events and opportunities by subscribing to our LinkedIn Newsletter:https://bit.ly/3RbdKtc or joining some of the largest groups most relevant to you: https://bit.ly/4caKquL (A-Z list)
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