Regulatory Blog

Earlier today (04 September, 2024) U.S. Food and Drug Administration's Center for Drug Evaluation and Research released the second...

Earlier this week, the World Health Organization (WHO) released draft guidelines "WHO Good Manufacturing Practices Considerations for the...

Nitrosamines have become a significant concern in the pharmaceutical industry due to their potential carcinogenicity. In response to this...

Today (04 August 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research and Center for Drug...

Last Friday (28 July, 2023) Health Canada published an updated "Guidance on Nitrosamine Impurities in Medications" that details about...

Today (12 July, 2023) the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia published a guideline on "Application of...

Health Canada last week published an updated "Guidance on Nitrosamine Impurities in Medications" that details about on Evaluating and...

On 18th November 2022 the UK's Medicines and Healthcare products Regulatory Agency released its updated guidance on the "European...

Nitrosamines are chemical compounds classified as probable human carcinogens on the basis of animal studies. EU regulators first became...