USA – FDA wants feedback on testing methods for new nitrosamines
The US Food and Drug Administration (FDA) is requesting stakeholder input on approaches for identifying and testing novel nitrosamines identified in drug products and...
Canada – Guidance : Nitrosamine impurities in medications
This guidance represents Health Canada's current thinking and recommendations on issues related to N-nitrosamine impurities (nitrosamine impurities or nitrosamines). This guidance may be subject to...
USA – FDA issues draft guidance on decentralized clinical trials
In a newly released draft guidance, the US Food and Drug Administration (FDA) is proposing recommendations on conducting decentralized clinical trials (DCTs) of drugs,...
USA – FDA issues final guidance on nicotine replacement therapy
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Monday issued a final guidance to assist sponsors interested...
USA – MedCon: TAP pilot off the ground four devices enrolled
The US Food and Drug Administration (FDA) has enrolled the first four devices in its Total Product Life Cycle Advisory Program (TAP) pilot, while...
