Top Regulatory Mistakes Companies Make (and How to Avoid Them)
Most regulatory failures don’t stem from a single bad decision. They develop quietly, over time, through small oversights that [...]
FDA Issues Testing Guidance: Testing of Ethanol and Isopropyl Alcohol
FDA Guidance Overview: The US FDA has issued guidance on the testing of Ethanol and Isopropyl Alcohol for Methanol. [...]
FDA Issues Testing Guidance: Drug Products Containing Carbomers
FDA Guidance Overview: The US FDA has recently (December 2023) issued immediate implementation guidance focusing on the reformulation of [...]
Revised Timelines for Nitrosamines Risk Assessment
On May 26, 2021, Health Canada extended the timelines for activities related to Nitrosamines Risk Assessment in consideration of [...]
What you need to know about Health Canada’s Regulatory Amendments for Non-Prescription Drug Products (GUI-0001)
Health Canada's regulatory amendment to the Food and Drugs Regulations Guidance Document GUI-0001 came into effect on July 1st [...]