Latest Developments and Insights

The pharmaceutical landscape is governed by strict regulatory frameworks that focuses the safety and efficacy of medications. In the United States, two primary pathways exist for drug approval: the New Drug Application (NDA) and the Abbreviated New Drug Application (ANDA).…

The FDA NDA review timeline can be complex, so it’s important to understand it during the drug development process. There are various stages and considerations involved in bringing a new pharmaceutical product to market. With an emphasis on scientific rigor…

Authorized by the 21st Century Cures Act , Food and Drug Administration’s (FDA) Oncology Center for Excellence (OCE) was established in January 2017. OCE was established to facilitate the development and clinical review of oncology products by uniting scientific experts…

Overview In the intricate world of drug development, the role of quality cannot be overstated. Ensuring the safety, efficacy, and reliability of pharmaceuticals is a cornerstone of the healthcare industry, as highlighted in the U.S. FDA’s Fiscal Year 2023 Report…

What is a biologic drug and how does it differ from a traditional small molecule drug? Biologic drugs have increasingly provided for broader therapeutic use over the last few decades and this trend is accelerating. As the first part of…

The simple answer is you save money, time and get an exciting new drug to the clinic for patients. What is Regulatory CMC and why do I need to pay attention to this during development? Regulatory CMC is at the…