# regulatory affairs (blogs) — RSS Amplifier Recent posts from the 4 feeds in the RSS Amplifier directory that cover regulatory affairs. Page: Feed: --- ## [Before its recent Phase 3 LSD win, Definium modeled up to $70,000 a year for a therapy that could fill a clinical shift](https://www.drugdiscoverytrends.com/before-its-recent-phase-3-lsd-win-definium-modeled-up-to-70000-a-year-for-a-therapy-that-could-fill-a-clinical-shift/) _2026-08-21 · Brian Buntz · Drug Discovery and Development_ New York City–based Definium recently announced positive data from its Phase 3 Voyage trial of DT120, an orally disintegrating 100 µg dose of LSD in adults with generalized anxiety disorder (GAD). The company announced positive Phase 3 results for the same compound for major depressive disorder (MDD) in June. Now the company needs to convince… The post Before its recent Phase 3 LSD win, Definium… ## [Metabolic stability: The defining challenge for multifunctional peptides](https://www.drugdiscoverytrends.com/metabolic-stability-the-defining-challenge-for-multifunctional-peptides/) _2026-08-20 · Dr. Hanlin Tao, Haijuan Liu · Drug Discovery and Development_ The demand for peptide therapeutics has grown rapidly in recent years, as the success of GLP-1 drugs has catapulted them to the forefront of developers’ and sponsors’ minds. Although peptides still represent a relatively small share of FDA-approved therapeutics, they offer distinct advantages in treating diseases where small-molecule drugs or therapeutic antibodies fall short. The… The post… ## [As 59% fewer pharma companies cut staff in Q2 in 2026, job postings rise 15%](https://www.drugdiscoverytrends.com/as-59-fewer-pharma-companies-cut-staff-in-q2-in-2026-job-postings-rise-15/) _2026-08-20 · Brian Buntz · Drug Discovery and Development_ 2022 was a big year for layoffs in biopharma. So were the next three. Novartis, for instance, outlined plans to cut up to 8,000 jobs in 2022, after pharmaceutical industry job cuts jumped 280% in 2021. Biogen followed in 2023 with a “Fit for Growth” program that put roughly 1,000 roles on the block. Bristol… The post As 59% fewer pharma companies cut staff in Q2 in 2026, job postings rise 15%… ## [How Sheba Medical Center became OpenAI’s first international hospital partner](https://www.drugdiscoverytrends.com/how-sheba-medical-center-became-openais-first-international-hospital-partner/) _2026-08-18 · Brian Buntz · Drug Discovery and Development_ OpenAI’s first international hospital partnership is taking shape at a giant medical center where English is not the default language and where the electronic health record does not come from Epic, the dominant U.S. EHR vendor. That institution is Sheba Medical Center, the Israel-based medical center with its own 50-plus-person AI Center within ARC, its… The post How Sheba Medical Center became… ## [FDA issues final PDUFA meeting guidance, expands use of written responses](https://www.drugdiscoverytrends.com/fda-issues-final-pdufa-meeting-guidance-expands-use-of-written-responses/) _2026-08-18 · Julia Rock-Torcivia · Drug Discovery and Development_ The FDA has finalized new guidelines for meetings between the FDA and sponsors or applicants relating to the development and review of drugs or biological products under the Prescription Drug User Fee Act (PDUFA). The FDA first published the draft guidance on Sept. 22, 2023, when it collected public comment on the guidelines. The final guidelines contain several changes from the draft, including… ## [Gilead and Nucleai probe why target-positive tumors can still resist ADCs](https://www.drugdiscoverytrends.com/gilead-and-nucleai-probe-why-target-positive-tumors-can-still-resist-adcs/) _2026-08-18 · Brian Buntz · Drug Discovery and Development_ Antibody-drug conjugates (ADCs) have emerged as one of the busiest and most crowded niches within oncology, given their potential to use an antibody to ferry a potent cytotoxic payload toward tumor cells. The class now spans about 15 FDA-approved products, and the segment is growing steadily. Evaluate Pharma projects the ADC category will reach $57… The post Gilead and Nucleai probe why… ## [Schrödinger-BMS collaboration centers on Bunsen for trillion-scale computational drug discovery](https://www.drugdiscoverytrends.com/schrodinger-bms-collaboration-centers-on-bunsen-for-trillion-scale-computational-drug-discovery/) _2026-08-17 · Brian Buntz · Drug Discovery and Development_ The 1990-founded scientific software firm Schrödinger recently announced a strategic collaboration and software agreement with Bristol Myers Squibb (BMS) built around Bunsen, Schrödinger’s newly announced agentic AI co-scientist. While the term “AI co-scientist” can have varying definitions, Schrödinger is positioning Bunsen as a sort of execution engine for computational chemistry, including… ## [The 50 best-funded biotech companies of 2026](https://www.drugdiscoverytrends.com/the-50-best-funded-biotech-companies-of-2026/) _2026-08-13 · Brian Buntz · Drug Discovery and Development_ By one measure, Alphabet-controlled Isomorphic Labs would tower over every company on this list. The AI drug discovery company has raised $2.7 billion in external financing, including a $2.1 billion Series B announced in May. Its corporate structure, however, puts it outside our definition of an independent biotech startup: Alphabet still controls at least 75%… The post The 50 best-funded biotech… ## [New cell imaging method reveals hidden enzyme activity](https://www.drugdiscoverytrends.com/new-cell-imaging-method-reveals-hidden-enzyme-activity/) _2026-08-13 · Julia Rock-Torcivia · Drug Discovery and Development_ Negative biosensors have often been unusable because, as the sensors lose signal when activity is detected, regions of high enzyme activity can look identical to regions with no activity. Researchers at the University of Illinois Chicago have solved this problem with a new cell imaging method that allows scientists to see previously hidden enzyme activities by flipping the optical readout of… The… ## [HHS seeks nominees for vaccine advisory panel with $757K estimated annual cost after almost two years without a meeting](https://www.drugdiscoverytrends.com/hhs-seeks-nominees-for-vaccine-advisory-panel-with-757k-estimated-annual-cost-after-almost-two-years-without-a-meeting/) _2026-08-13 · Julia Rock-Torcivia · Drug Discovery and Development_ The Department of Health and Human Services (HHS) is soliciting nominations for appointment to the National Vaccine Advisory Committee (NVAC), the agency said in a notice published Wednesday. A renewed NVAC charter filed in July estimates the committee’s annual operating cost at $756,918 and calls for staff support equivalent to two full-time employees. The committee has not met since September… ## [Collect Open Source Legends (Sponsored)](https://crawlproof.com/a/MsV8yH7StDeD) _2026-08-13 · **Sponsored**_ Open-licensed art, limited foil trading packs, and optional on-chain mints. ## [Novo Nordisk’s ziltivekimab misses Phase 3 primary endpoint](https://www.drugdiscoverytrends.com/novo-nordisks-ziltivekimab-misses-phase-3-primary-endpoint/) _2026-08-12 · Julia Rock-Torcivia · Drug Discovery and Development_ Novo Nordisk’s ziltivekimab, an investigational human monoclonal antibody that targets the IL-6 ligand, a pro-inflammatory cytokine, to reduce cardiovascular inflammation, did not reduce the risk of major adverse cardiovascular events (MACE) in a Phase 3 trial. “Although ziltivekimab produced the expected biological effect, this did not result in MACE benefits in this population,” Martin Holst… ## [State AI Laws Make Data Provenance a Legal Requirement](https://sayari.com/resources/blog/data-provenance-state-ai-laws/) _2026-08-11 · Sayari Content Team · Sayari_ The United States has federal AI law, and the effort to impose a regulatory framework on AI is contested and far from settling. What has emerged instead is a patchwork of state statutes that look, at first, like they solve different problems. California regulates the provenance of AI-generated content. Colorado and Texas regulate consequential AI \[…\] The post State AI Laws Make Data Provenance a… ## [Issue 16: Same Title, Different Career: How to Read MedTech RA Roles](https://beyondtheregulation.substack.com/p/issue-16-same-title-different-career) _2026-08-03 · Beyond Regulation with Ceren: Insights, Career & MedTech_ The same Regulatory Affairs title can describe completely different careers. What the role actually looks like often depends on multiple factors. Read the details in this week´s edition. ## [Issue 15: Where Does Regulatory Affairs End and Quality Assurance Begin?](https://beyondtheregulation.substack.com/p/issue-15-where-does-regulatory-affairs) _2026-07-21 · Beyond Regulation with Ceren: Insights, Career & MedTech_ Why are Regulatory Affairs and Quality Assurance often combined in MedTech SMEs and what does this mean for your career? This issue explores RAQA integration, a peanut allergen reagent recall involving false-negative risks, and the importance of robust manufacturing controls ## [Issue 14: How Regulatory Affairs Changed the Way I See Everyday Things?](https://beyondtheregulation.substack.com/p/issue-14-how-regulatory-affairs-changed) _2026-07-07 · Beyond Regulation with Ceren: Insights, Career & MedTech_ Ever noticed how regulatory affairs changes the way you look at everyday things? This week's issue is about exactly that. ## [Inside China’s New Counter-Sanctions Regime: Orders 834 and 835](https://sayari.com/resources/blog/china-counter-sanctions/) _2026-07-01 · Sayari Content Team · Sayari_ China’s State Council recently issued two orders that change the rules around how foreign companies can investigate their supply chains inside China, and how far they can go in enforcing Western sanctions against Chinese counterparties. State Council Order No. 834 (the Provisions on Industrial and Supply Chain Security, effective April 7, 2026) elevates Chinese regulatory \[…\] The post Inside… ## [Issue 13: Free Resources to polish your technical knowledge](https://beyondtheregulation.substack.com/p/issue-13-what-are-you-doing-with) _2026-06-23 · Beyond Regulation with Ceren: Insights, Career & MedTech_ Q4 is one of the quarters when companies hire the most. Are you preparing for it? ## [1260h list update](https://sayari.com/resources/blog/1260h-list-update/) _2026-06-15 · Sayari Content Team · Sayari_ On June 8, 2026, the Department of Defense published its updated list of Chinese military companies under Section 1260H. The list names 188 entities, primary designees and their explicitly identified subsidiaries. Contracting prohibitions take effect June 30. For defense primes, that deadline is urgent. But the downstream ownership risk embedded in this list reaches far \[…\] The post 1260h list… ## [Issue 12: Change Control Approved: Switching to Summer](https://beyondtheregulation.substack.com/p/issue-12-change-control-approved) _2026-06-09 · Beyond Regulation with Ceren: Insights, Career & MedTech_ Give me a beach, a cold drink, and absolutely no agenda. That is my summer. ## [Future Opportunities in the CSV Job Market and Career Growth Trends for 2026](https://www.companysconnects.com/post/future-opportunities-in-the-csv-job-market-and-career-growth-trends-for-2026) _2026-05-30 · companyconnectc · Skillbee Solution Services_ The job market is evolving rapidly, and understanding where opportunities lie is crucial for anyone planning their career path. One area gaining attention is the CSV (Comma-Separated Values) job market, which relates to roles involving data handling, analysis, and management using CSV files. As data continues to drive decision-making across industries, the demand for professionals skilled in… ## [Find it on Amazon (Sponsored)](https://crawlproof.com/a/37G1rOBtLJIp) _2026-05-30 · **Sponsored**_ Open the Amazon product listing to see details and availability ## [Best Drug Regulatory Affairs Courses to Get Job-Ready](https://www.companysconnects.com/post/best-drug-regulatory-affairs-courses-to-get-job-ready) _2026-05-26 · companyconnectc · Skillbee Solution Services_ In today’s rapidly evolving pharmaceutical landscape, having a solid understanding of Drug Regulatory Affairs (DRA) isn’t just an advantage — it’s often a requirement for those seeking meaningful careers in pharma, biotechnology, medical devices, clinical research, and related sectors. As global regulatory frameworks become more complex and stringent, demand for trained regulatory affairs… ## [Alert Adjudication and the AMLA Standard](https://sayari.com/resources/blog/alert-adjudication-amla/) _2026-05-26 · Sayari Analyst Team · Sayari_ Alert adjudication is the critical success factor for financial crime compliance. Analysts must swiftly distinguish genuine risk from false positives while meeting operational and regulatory standards — yet the process across UK and European institutions is currently under question. Screening systems are at risk of producing 90–95% false positive rates, costing an estimated $206 billion globally,… ## [Issue 11: How to Choose? Small company vs Corporate Setting](https://beyondtheregulation.substack.com/p/issue-11-why-staying-current-on-regulatory) _2026-05-26 · Beyond Regulation with Ceren: Insights, Career & MedTech_ This issue focuses on why staying updated with RA news matters for interviews and how to think about the “small company vs corporate” career choice. I also highlight an interesting LinkedIn post that shares a useful tip for reading job descriptions. ## [Enhancing CSV Validation with Agile and DevOps Practices](https://www.companysconnects.com/post/enhancing-csv-validation-with-agile-and-devops-practices) _2026-05-25 · companyconnectc · Skillbee Solution Services_ Data validation plays a critical role in ensuring the accuracy and reliability of information systems. When working with CSV files, which are widely used for data exchange and storage, validation becomes even more important. Traditional validation methods often struggle to keep pace with the speed and complexity of modern development cycles. This is where Agile and DevOps practices can transform… ## [Issue 10: Regulatory Affairs: The Art of Stakeholder Debate](https://beyondtheregulation.substack.com/p/issue-10-regulatory-affairs-the-art) _2026-05-19 · Beyond Regulation with Ceren: Insights, Career & MedTech_ What each stakeholder prioritzes in MedTech, interesting recall and career transition to RA from other departments in MedTech ## [Issue 9: Why I Sit Through the Whole Audit?](https://beyondtheregulation.substack.com/p/issue-9-why-i-sit-through-the-whole) _2026-05-12 · Beyond Regulation with Ceren: Insights, Career & MedTech_ Another audit with a Notified body, my takey from 2,5 days of audit and implementing regulation that will change the everyday life of RA and QA professionals. ## [Moosavi Hezbollah Network](https://sayari.com/resources/blog/moosavi-hezbollah-network/) _2026-05-11 · Sayari Content Team · Sayari_ On April 15, 2026, the U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC) designated Iranian national Seyed Badroddin Naiemaei Moosavi, along with three of his front companies, for orchestrating a complex oil-for-gold money laundering scheme that generated hundreds of millions of dollars for Hezbollah and Iran’s Islamic Revolutionary Guard Corps–Qods Force (IRGC-QF). Prior… ## [Iran Sanctions and Tariffs CFO](https://sayari.com/resources/blog/iran-sanctions-tariffs-cfo/) _2026-05-07 · Sayari Content Team · Sayari_ Once mainly followed by compliance and supply chain professionals, sanctions and tariffs are now the topics of the hour. In February, the U.S. Supreme Court ruled in Learning Resources, Inc. v. Trump that the International Emergency Economic Powers Act, which the Administration used as legal basis for its tariff regime, does not authorize the President to impose \[…\] The post Iran Sanctions and… ## [Issue 8: Why Nobody Teaches You How to Get a Job in Regulatory Affairs?](https://beyondtheregulation.substack.com/p/issue-8-why-nobody-teaches-you-how) _2026-05-05 · Dr. Ceren Karacay-Steinwender · Beyond Regulation with Ceren: Insights, Career & MedTech_ Explore why preparation is key to success, the use of ChatGP for interview prep, and signs of a fake QMS. ## [Issue 7: Why do I suggest free courses?](https://beyondtheregulation.substack.com/p/issue-7-why-do-i-suggest-free-courses) _2026-04-28 · Beyond Regulation with Ceren: Insights, Career & MedTech_ There is a lot of information available. Regulations, guidance documents, videos, posts, discussions. But without context, it often feels like pieces that don’t fully connect. ## [Ask the crowd: AI or not (Sponsored)](https://crawlproof.com/a/5yf6hJSTMG0n) _2026-04-28 · **Sponsored**_ Get a transparent verdict from verified humans via web, RSS, or API. ## [Issue 6: Why breaking into Regulatory Affairs is "that hard"?](https://beyondtheregulation.substack.com/p/issue-6-why-breaking-into-regulatory) _2026-04-21 · Beyond Regulation with Ceren: Insights, Career & MedTech_ Everyone says breaking into Regulatory Affairs is “hard.” And honestly? They’re not wrong. ## [Issue 5: Why do I write about recalls?](https://beyondtheregulation.substack.com/p/issue-5-why-do-i-write-about-recalls) _2026-04-14 · Dr. Ceren Karacay-Steinwender · Beyond Regulation with Ceren: Insights, Career & MedTech_ Vigilance requirements are rarely black and white. They depend on your product, how well you know it, your experience, and… context. ## [Issue 4: Why did I start this newsletter?](https://beyondtheregulation.substack.com/p/issue-4-why-did-i-start-this-newsletter) _2026-04-07 · Beyond Regulation with Ceren: Insights, Career & MedTech_ I am interested in many aspects of regulatory affairs. Not just one corner of it. And more importantly, I have always been interested in people and their careers. ## [Sub-Tier Supplier Onboarding](https://sayari.com/resources/blog/sub-tier-supplier-onboarding/) _2026-04-01 · Ben Power · Sayari_ Most compliance programs send questionnaires to direct suppliers and assume certification equals compliance. That model has fractured under UFLPA enforcement. CBP now requires documentation of actual sourcing tracing inputs to geographic origin-a supplier’s assertion alone is indefensible if trade or customs data shows otherwise. The gap is acute. Questionnaire programs fail when tier-one… ## [Industrial MEU Export Controls](https://sayari.com/resources/blog/industrial-meu-export-controls/) _2026-04-01 · Ben Power · Sayari_ Your compliance team screens customer names against the BIS Entity List before every shipment. But here’s what keeps you up at night: that check isn’t enough anymore. The assumption that watchlist screening protects your products from military diversion is fracturing. Watchlist screening alone no longer protects your products from military diversion. The Bureau of Industry and \[…\] The post… ## [Sensitive Tech Flow to Adversaries](https://sayari.com/resources/blog/sensitive-tech-flow-adversaries/) _2026-04-01 · Ben Power · Sayari_ The Export Administration Regulations (EAR) assumed that listing sensitive technology, licensing transfers, and maintaining entity watchlists would stop adversaries from acquiring it. That model fails today. Sensitive technology reaches adversaries not because the EAR is weak on paper, but because its enforcement is blind: regulators identify restricted technology but cannot reliably see who… ## [Semiconductor Industry Shift](https://sayari.com/resources/blog/semiconductor-industry-shift/) _2026-04-01 · Ben Power · Sayari_ For decades, the semiconductor industry operated on the principle of cross-border specialization: American design, Dutch and Japanese equipment manufacturing, Taiwanese and South Korean fabrication, Chinese assembly. The logic was efficient and deeply embedded in global trade. That assumption no longer holds. The CHIPS and Science Act in August 2022 authorized $52.7 billion in direct subsidies \[…\]… ## [Issue 3: I moved from pharma RA to MedTech RA. Here’s what surprised me the most.](https://beyondtheregulation.substack.com/p/issue-3-i-moved-from-pharma-ra-to) _2026-03-31 · Beyond Regulation with Ceren: Insights, Career & MedTech_ What moving from pharma RA to MedTech RA taught me ## [Issue 2: Why I am on a mission to help others in Regulatory Affairs!?](https://beyondtheregulation.substack.com/p/issue-2-why-i-am-on-a-mission-to) _2026-03-24 · Dr. Ceren Karacay-Steinwender · Beyond Regulation with Ceren: Insights, Career & MedTech_ To this day, I’ve had one major and one minor career pivot. ## [Issue 1: Welcome to my world!](https://beyondtheregulation.substack.com/p/issue-1-welcome-to-my-world) _2026-03-17 · Dr. Ceren Karacay-Steinwender · Beyond Regulation with Ceren: Insights, Career & MedTech_ You may know me from LinkedIn, or maybe this is your first time seeing my newsletter. ## [Understanding the Crucial Role of Computerized System Validation in Today's Tech Landscape](https://www.companysconnects.com/post/understanding-the-crucial-role-of-computerized-system-validation-in-today-s-tech-landscape) _2026-03-11 · companyconnectc · Skillbee Solution Services_ Computerized systems power nearly every aspect of modern technology, from healthcare devices to financial software. Ensuring these systems work correctly and reliably is not just a technical concern but a critical requirement for safety, compliance, and trust. Computerized System Validation (CSV) plays a vital role in confirming that software and hardware meet their intended purpose consistently… ## [Why Recruiters Prefer Trained Regulatory Affairs Candidates](https://www.companysconnects.com/post/why-recruiters-prefer-trained-regulatory-affairs-candidates) _2026-03-11 · companyconnectc · Skillbee Solution Services_ Introduction: The Changing Hiring Standards in Regulatory Affairs The pharmaceutical industry has become more regulated and competitive than ever before, and Regulatory Affairs plays a central role in ensuring compliance and patient safety. Recruiters today are no longer satisfied with academic qualifications alone. They actively seek trained Regulatory Affairs candidates who can understand… ## [Best Pharma Courses in India with 100% Placement Assistance – Complete Industry Guide 2026](https://www.companysconnects.com/post/best-pharma-courses-in-india-with-100-placement-assistance-complete-industry-guide-2026) _2026-03-11 · companyconnectc · Skillbee Solution Services_ The Indian pharmaceutical industry is growing faster than ever. With India being one of the largest suppliers of generic medicines globally and home to world-renowned pharma giants like Sun Pharmaceutical Industries, Dr. Reddy's Laboratories, Cipla, Lupin Limited, and Aurobindo Pharma, the demand for skilled pharma professionals is at an all-time high. Every year, thousands of B.Pharm, M.Pharm,… ## [Why LIMS Training Is Essential for QC & QA Professionals](https://www.companysconnects.com/post/why-lims-training-is-essential-for-qc-qa-professionals) _2026-03-10 · companyconnectc · Skillbee Solution Services_ Quality Control (QC) and Quality Assurance (QA) professionals play a critical role in ensuring that products meet strict standards and regulations. In laboratories and manufacturing environments, the Laboratory Information Management System (LIMS) has become an essential tool for managing data, workflows, and compliance. Yet, many organizations overlook the importance of proper LIMS training for… ## [How LIMS Training Helps You Get Placed in Top Pharma Companies](https://www.companysconnects.com/post/how-lims-training-helps-you-get-placed-in-top-pharma-companies) _2026-03-02 · companyconnectc · Skillbee Solution Services_ The pharmaceutical industry is evolving faster than ever. With increasing regulatory scrutiny, digital transformation, and a strong focus on data integrity, pharma companies are no longer relying on manual processes. One system that has become absolutely essential across quality control and laboratory operations is LIMS (Laboratory Information Management System) . If you’re a fresher, working… ## [Online Regulatory Affairs Course with Certificate – Your Complete Career Guide for 2026](https://www.companysconnects.com/post/online-regulatory-affairs-course-with-certificate-your-complete-career-guide-for-2026) _2026-03-01 · companyconnectc · Skillbee Solution Services_ The pharmaceutical and healthcare industry is evolving faster than ever. New drug approvals, stricter compliance frameworks, global harmonization guidelines, and digital regulatory submissions have transformed how companies operate. In this competitive landscape, one thing has become very clear — regulatory expertise is no longer optional; it is essential. If you are exploring a career in pharma,… ## [Skills Required to Get a LIMS Job in Pharma Companies](https://www.companysconnects.com/post/skills-required-to-get-a-lims-job-in-pharma-companies) _2026-02-27 · companyconnectc · Skillbee Solution Services_ The pharmaceutical industry today runs on data. Every sample tested, every batch released, every deviation recorded, and every stability study conducted generates a trail of critical information. Behind this organized flow of laboratory data stands one powerful system — the Laboratory Information Management System, commonly known as LIMS. If you are aiming for a LIMS job in pharma companies, you…