Clinical outcome assessments (COAs) are a critical component of clinical trials and regulatory submissions for regulatory agencies like the US FDA. The US FDA defines a COA as a “measure that describes or reflects how a patient feels, functions, or survives”; COAs provide important information to the US FDA on the effectiveness of therapies so […]
The Use of Item Response Theory in Clinical Outcome Assessments Read More »
Recent years have witnessed a surge in clinical practice data generation outside of trials, driven by advanced signal detection technologies and expanded database capabilities. The integration of real-world data (RWD) with artificial intelligence (AI) tools is reshaping regulatory and medical decision-making. Various user-generated practice data types are stored in centralized databases, offering valuable longitudinal observations
Utilizing Real-World Evidence for Medical Devices Read More »
Pharmaceutical companies have faced delays in receiving a response to their Suitability Petitions by the United States Food and Drugs Administration (US FDA). This has been a problem as delay in responses have led to the delay of Abbreviated New Drug Applications (ANDA) entering the market. The US FDA has committed to proactively reviewing the
Reforming ANDA Suitability Petitions Read More »
The International Recognition Procedure (IRP), initiated by the Medicines and Healthcare products Regulatory Agency (MHRA) post-Brexit, establishes an international recognition route for medicines with pre-existing approvals from Canada, Australia, the EU, Japan, Switzerland, and the US. Operating alongside existing national procedures, the IRP is a crucial pathway for introducing innovative medications to UK patients while
Online Eligibility Checker Tool for International Recognition Procedure Read More »
The UK Medicines and Healthcare products Regulatory Agency (MHRA) receives approximability 1000 clinical trial authorization (CTA) applications a year. These are for investigational medicinal products of which >95% are approved. However, >50% still need additional information to be submitted in order to get approved. The majority of the requests for additional information, including “grounds for
UK MHRA: Navigating Nuances in Clinical Trial Applications Read More »
The importance of aligning pharmaceutical regulations in the development process has become increasingly evident particularly in the current era that has characterized by global interconnectedness. Indeed, the need for harmonizing frameworks that govern medicine regulation and subsequently supporting bilateral trade has increasingly become imperative. As various pharmaceutical markets go beyond borders, disparities in their respective
Fostering bilateral trade and harmonized efforts in medicine regulation Read More »
The medical device sector in Argentina and Brazil is experiencing robust growth and development to keep up with the demand in more comprehensive options to diagnose, prevent, and treat complicated conditions. Indeed, rising healthcare demands and an increase in the awareness of advanced medical technologies propel a surge in the adoption of innovative devices. Coupled
ANVISA & ANMAT: Mutual Recognition Agreement for Medical Devices Read More »
Electronic Product Information (ePI) is authorized, statutory information for medicines, covering patient information leaflets and the Summary of Product Characteristics for healthcare professionals. It adheres to a semi-structured format with the common EU electronic standard, optimized for electronic handling, internet dissemination, and compatibility with healthcare information systems. Despite print options, the primary aim of ePI
Advancing Healthcare through Electronic Product Information Read More »
The emergence of drug shortages as a significant global health concern is evident. Organisations including the European Medicines Agency (EMA) express concerns about long-term medicine availability, emphasizing the need for continuous access to high-quality, affordable essential medicines. Shortages lasting days or months jeopardize patient outcomes, straining healthcare systems. EMA has introduced a solidarity mechanism, developed
How is EMA Addressing Medicine Shortages in Europe? Read More »
The use of artificial intelligence (AI) in the Pharmaceutical and Health Care industries has paved the way for more innovative opportunities to help enhance patient outcomes. This is with respect to the diagnosis, treatment, and overall personalized patient care. However, as these technologies evolve, so do the challenges especially when it comes to testing these
MHRA’s AI-Airlock for Safe Development of Medical Technologies Read More »
