A Contract Research Organization (CRO) is a company that provides research services to pharmaceutical, biotech, and medical device companies on a contract basis. CROs play a crucial role in the drug development process, providing support in areas such as clinical trials, regulatory affairs, and data management. CROs can range in size from small startups to …
A Biologics License Application (BLA) is a submission that a biopharmaceutical company makes to the US Food and Drug Administration (FDA) seeking approval to market a biological product, such as a vaccine, blood product, or gene therapy. BLAs are a crucial step in the development and approval process for biologic products. They provide the FDA …
Understanding the BLA Process: A Crucial Step for Biologic Products Approval Read More »
The World Health Organization (WHO) is a specialized agency of the United Nations responsible for global public health. It was established on April 7, 1948, and is headquartered in Geneva, Switzerland. WHO’s mission is to build a better, healthier future for people all over the world by promoting health, keeping the world safe, and serving …
Outcomes-Based Agreements (OBA) are a relatively new approach to drug pricing and reimbursement that have gained popularity in recent years. In this article, we will explore what OBA are, how they work, and their importance to the pharmaceutical industry. What are Outcomes-Based Agreements? Outcomes-Based Agreements are contracts between payers, such as insurance companies or governments, …
Health Technology Assessment (HTA) is a multidisciplinary field of research that evaluates the clinical, economic, and social value of medical interventions. The Market Access function within pharmaceutical companies typically apply for HTA to secure optimal market access for their products. In this article, we will explore the HTA process and the countries where it is …
Health Technology Assessment (HTA): Evaluating the Value of Medical Interventions Read More »
Gross-to-net adjustments (GTN) is a term used in the pharmaceutical industry to describe the process of adjusting the gross sales revenue of a product to arrive at the net revenue after accounting for various discounts, rebates, and other deductions. In this article, we will explore the meaning of GTN and its importance in the pharmaceutical …
Gross-to-Net Adjustments (GTN) in Pharmaceutical Sales: Understanding the Process Read More »
