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The Food Safety and Standards Authority of India (FSSAI) has been working towards a Front-of-Pack warning-label framework for packaged foods that are high in nutrients of concern, including sugar, salt and fat. The proposed approach is intended to make important nutritional information more visible at the point of purchase. FSSAI’s latest pr...
In the rapidly evolving landscape of clinical research, Contract Research Organizations (CROs) are pivotal in accelerating drug, device, and biologic development while navigating regulatory complexities and operational challenges. As of 2026, the APAC CRO market is valued at approximately USD 21.07 billion in 2024 and projected to reach USD 40.01 b...
Artificial intelligence is moving from experimentation to execution in clinical research. The opportunity is to use AI, machine learning and NLP to improve how clinical development teams make decisions. Clinical trials have always been data-intensive. What has changed is the scale, speed and diversity of the data being generated. Today, clinical de...
A case study in managing 40 sites, nearly 600 randomized subjects and complex clinical endpoints across multiple geographies Complex ophthalmology trials require precise site execution, strong patient engagement, robust data management, rigorous statistical analysis and continuous regulatory readiness. Navitas Life Sciences, a global CRO, conducted...
pharmaREADY 2026: Building the Future of Regulatory Operations with AI, eCTD 4.0 and Connected Technology From regulatory publishing to intelligent, connected regulatory operations, the latest pharmaREADY User Group Meeting brought together industry perspectives, technology roadmaps and practical insights on what comes next. On August 27, 2026, Nav...
FDA’s New Draft Guidance on Container Closure Systems: What Drug Developers Need to Know A risk-based approach puts packaging suitability, compatibility and performance firmly within the broader CMC strategy For nearly three decades, the FDA’s approach to container closure systems (CCSs) for human drugs and biological products has bee...
From diabetes management to obesity, cardiovascular risk and emerging metabolic indications, GLP-1 therapies are changing what sponsors expect from clinical development. The next challenge is not simply developing another GLP-1. It is designing and executing the right study, in the right patients, with the right evidence. The GLP-1 revolution has m...
What pharmaceutical companies in India need to know about Schedule M, inspection readiness and building an effective pharmacovigilance system On 3 June 2026, CDSCO issued a circular on the implementation of the Pharmacovigilance (PV) System under Schedule M of the Drugs & Cosmetics Act, 1940 and the Rules made thereunder. The circular specifica...
The U.S. biopharmaceutical industry is entering a new phase of innovation, one shaped by increasing R&D costs, impending patent expirations and the growing need to strengthen development pipelines through external innovation. As a result, cross-border licensing has become an important strategy for biopharma companies seeking to accelerate drug ...
Five Mistakes Companies Make During eCTD 4.0 Implementation And How to Avoid Them The regulatory landscape is entering one of its most significant periods of transformation since the adoption of electronic submissions. As health authorities worldwide prepare for eCTD 4.0 implementation, pharmaceutical, biotechnology and medical device companies fac...