BLOGS BLOGS 21Nov November 21, 2024 Navigating the New Requirements for Diversity in Clinical Trials 18Nov November 18, 2024 What Biologics Developers Need to Know about ICH Q2 and Q14 Revisions 15Nov November 15, 2024 Accelerating Drug Development with Europe’s New Clinical Trial Pilots 14Nov November 14, 2024 What does the scenario of biosimilar cell and gene therapies look like? 11Nov November 11, 2024 Complying with Safety Reporting Requirements in the EU’s CTD to CTR Transition 06Nov November 6, 2024 FDA Launches REMS Public Dashboard to Enhance Transparency and Data Access 04Nov November 4, 2024 Designing Effective Pharmaco-Epidemiological Studies with ICH’s M14 30Oct October 30, 2024 Understanding Post-Approval Manufacturing Changes in Biosimilars and Interchangeable Products in USA 25Oct October 25, 2024 Updates to the Declaration of Helsinki 22Oct October 22, 2024 Navigating EU Classification Standards for AI in Medical Devices and Diagnostics 16Oct October 16, 2024 Expediting Access to Cell and Gene Therapy Products 15Oct October 15, 2024 Enhancing Medical Device Innovation with the Total Product Life Cycle Advisory Program 08Oct October 8, 2024 Exploring the Evolving Regulatory Landscape for Gene Therapy Trials in the EU 23Sep September 23, 2024 Japan’s Approach to eCTD V4.0 17Sep September 17, 2024 Does the FDA need a new approval pathway? 14Sep September 14, 2024 Regulatory Framework for Software and Artificial Intelligence as Medical Device 03Sep September 3, 2024 Navigating the 505(b)(2) Approval Pathway 30Aug August 30, 2024 Specifications for In Vitro Diagnostic Devices 28Aug August 28, 2024 Faster Access to Clinical Trial Information in Europe 23Aug August 23, 2024 The Use of EDDO to Ensure Drug Delivery Function 20Aug August 20, 2024 Emerging Drug Safety Technology Program 12Aug August 12, 2024 Ensuring Transparency for Machine Learning-Enabled Medical Devices 08Aug August 8, 2024 Clinical Evaluation of Orphan Medical Devices 30Jul July 30, 2024 Recommendations for the use of Animal & Human Derived Materials in Cell and Gene Therapy Products 29Jul July 29, 2024 Accelerating Product Registration with SFDA’s Priority Review 25Jul July 25, 2024 REMS Logic Model: Framework to link program design with assessment 22Jul July 22, 2024 Impact of GenAI on Indian Healthcare 19Jul July 19, 2024 Machine Learning and Simulations for Clinical Trials 11Jul July 11, 2024 The Impact of Interactive Safety Graphics in Clinical Settings 08Jul July 8, 2024 Comprehensive Framework for Effective Clinical Trial Dialogue 03Jul July 3, 2024 Accelerating Clinical Trials in the European Union 25Jun June 25, 2024 Enhancing Global Drug Development through ICH M11 14Jun June 14, 2024 Leveraging Statistical Approaches in Drug Safety Analysis 30May May 30, 2024 Center for Clinical Trial Innovation 28May May 28, 2024 Data Integrity for In Vivo BABE Studies 21May May 21, 2024 Electronic Submissions for Investigational New Drug Safety Reports 14May May 14, 2024 A Collaborative Approach Towards Integrating Artificial Intelligence in Medical Products 13May May 13, 2024 Enhancing Clinical Trial Regulations for Advanced Therapy Medicinal Products 08May May 8, 2024 Pharmacovigilance in New Zealand 07May May 7, 2024 Designing Early-Phase Clinical Trials for Cell and Gene Therapy Products 02May May 2, 2024 Navigating Orphan Drug Regulations for Gene Therapy Products 24Apr April 24, 2024 Conducting Clinical Trials for Investigational Products in Brazil 22Apr April 22, 2024 Controlled Correspondence for Generic Drug Development 18Apr April 18, 2024 CMC Considerations for Human Gene Therapy INDs 17Apr April 17, 2024 Commitment to Biological Product and Patient Safety in India 15Apr April 15, 2024 Empowering Rare Disease Drug Developers 08Apr April 8, 2024 How is Team AB Gearing up for the new MedTech Legislation? 01Apr April 1, 2024 Harmonization for the Development of Cell and Gene Therapies 28Mar March 28, 2024 Essential Aspects of Labeling for Clinical Supplies and Investigational Products 26Mar March 26, 2024 Assessing COVID-19 Symptoms in Clinical Trials 20Mar March 20, 2024 Asserting Patient Rights: The Importance of Labels for Medical Device Traceability 13Mar March 13, 2024 Submitting Revised ANDA Labels to Ensure Safety & Compliance 04Mar March 4, 2024 Development of CAR T Cell Products 27Feb February 27, 2024 Model-Integrated Evidence Program for Generic Drugs 22Feb February 22, 2024 Searchable Databases for Bio-Equivalence Guidance 14Feb February 14, 2024 Increasing Harmonization for Complex Generics 12Feb February 12, 2024 Strengthening Safety Compliance in Somalia 08Feb February 8, 2024 Ensuring Viral Safety of Biotechnology Products 05Feb February 5, 2024 Regulatory Roadmap for Access to MedTech 02Feb February 2, 2024 Fostering Medical Innovation with Expedited Review Processes 29Jan January 29, 2024 Easing Requirements for Minimal Risk Clinical Trials 25Jan January 25, 2024 Standardizing Real World Data for Drug and Biological Product Submissions 23Jan January 23, 2024 Streamlining Clinical Investigations for Medical Devices 18Jan January 18, 2024 Third Party Review Program for Medical Devices 15Jan January 15, 2024 SwissMedic: Strengthening Safety Signal Reporting for Veterinary Products 11Jan January 11, 2024 Effective Communication for the Safe Use of Biosimilars 08Jan January 8, 2024 Indian Pharmacopoeia Commission: Safety Alert for Mefenamic Acid 05Jan January 5, 2024 The Use of Item Response Theory in Clinical Outcome Assessments 03Jan January 3, 2024 Enhancing Medical Device Cybersecurity 02Jan January 2, 2024 Utilizing Real-World Evidence for Medical Devices 21Dec December 21, 2023 Reforming ANDA Suitability Petitions 19Dec December 19, 2023 Online Eligibility Checker Tool for International Recognition Procedure 15Dec December 15, 2023 UK MHRA: Navigating Nuances in Clinical Trial Applications 12Dec December 12, 2023 Fostering bilateral trade and harmonized efforts in medicine regulation 07Dec December 7, 2023 ANVISA & ANMAT: Mutual Recognition Agreement for Medical Devices 04Dec December 4, 2023 Advancing Healthcare through Electronic Product Information 28Nov November 28, 2023 How is EMA Addressing Medicine Shortages in Europe? 22Nov November 22, 2023 Kenya’s Systematic Approach to Pharmacovigilance 20Nov November 20, 2023 MHRA’s AI-Airlock for Safe Development of Medical Technologies 17Nov November 17, 2023 Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices 16Nov November 16, 2023 ISoP: The Need for Patient Engagement in Pharmacovigilance 07Nov November 7, 2023 AMDF: Ensuring the Safety of Donated Medical Devices 02Nov November 2, 2023 Japan PMDA: The Role of In-Country Clinical Caretakers 31Oct October 31, 2023 Regulatory Framework for Cosmetics in South Korea 27Oct October 27, 2023 Pharmacovigilance in Herbal and Alternative Medicine 19Oct October 19, 2023 Supporting Labelling Compliance with Searchable Databases 17Oct October 17, 2023 Swissmedic: The Importance of Real-World Evidence in Regulatory Decision Making 11Oct October 11, 2023 Modernization of Cosmetics Regulation Act 10Oct October 10, 2023 Ensuring Safe Use of Medical Devices in Healthcare Facilities 04Oct October 4, 2023 Evaluating the need for comparative clinical efficacy studies in biosimilar development 03Oct October 3, 2023 Prescription-Drug-Use-Related Software 28Sep September 28, 2023 Requesting Post-Warning Letter Meetings 20Sep September 20, 2023 UK MHRA International Recognition Procedure 14Sep September 14, 2023 Formal Meetings for Biosimilar Product Development with the US FDA 12Sep September 12, 2023 Paediatric Investigation Plan in Medicinal Product Development 05Sep September 5, 2023 Packaging Requirements for the Safety of Children 01Sep September 1, 2023 Post-market safety data for underrepresented populations in clinical trials 29Aug August 29, 2023 How to prepare for oral explanations with EMA 24Aug August 24, 2023 Guidance on Informed Consent in Clinical Investigations 22Aug August 22, 2023 Diversity Plan in Clinical Trials
