Paving the Future: Exploring the Advanced Manufacturing Technologies Designation Program The FDA’s draft guidance on the Advanced Manufacturing Technologies Designation Program was published on December 13, 2023. It’s important to note that the program is still in draft form, and the deadline for public comments is February 12, 2024. So while the program has been […]

Unveiling the Potential of Cannabinoids: A Journey Through Research, Regulatory Progress and Future Prospects In the realm of medical science, an intriguing avenue is rapidly gaining momentum – cannabinoid-based therapeutics. These compounds, sourced from the cannabis plant, have emerged as a promising solution for an array of medical conditions. Extensive research has unveiled their therapeutic

A Basic Guide to Chemistry, Manufacturing and Controls (CMC) Module for an Investigational New Drug Application (IND) IND CMC stands for Investigational New Drug Chemistry, Manufacturing, and Controls. It is a regulatory module that must be submitted to the FDA (or other regulatory agency) when seeking approval to conduct clinical trials for a new drug.

How N-nitrosodimethylamine (NDMA) or Nitrosamine impurity is impacting the Pharma industry NDMA stands for N-nitrosodimethylamine, which is a chemical compound and belongs to a class of chemicals known as nitrosamines. NDMA is an organic compound with the chemical formula C₂H₆N₂O. It is a highly potent and toxic substance, classified as a probable human carcinogen by