Latest Developments and Insights

In the dynamic landscape of biopharmaceutical development, adherence to evolving international standards is crucial. The recent updates from International Council for Harmonisation (ICH) Q2 “Validation of Analytical Procedures” from Revision 1 to Revision 2, coupled with the introduction of ICH…

In today’s highly regulated industries, compliance with regulatory standards is crucial for business success and public safety. Regulatory affairs professionals play a vital role in managing the complex processes involved in meeting these standards, from product development to market approval.…

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…