FDA-GUIDELINES

FDA-GUIDELINES

Managing Nitrite Impurities A Supplier-Manufacturer Approach To Mitigating Nitrosamine Risk

Introduction Nitrosamines, once a hidden threat in the pharmaceutical industry, have recently come under intense scrutiny. These potentially carcinogenic compounds have been found in various medications, prompting a global response from manufacturers and regulatory bodies..

FDA-GUIDELINES

Data Quality Issues At The Heart Of FDA's DSCSA Troubles

The Struggle for Seamless Pharmaceutical Traceability The Food and Drug Administration (FDA) has recently announced a series of delays and guidelines for the implementation of the Drug Supply Chain ..