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USA – FDA issues draft guidance on decentralized clinical trials
In a newly released draft guidance, the US Food and Drug Administration (FDA) is proposing recommendations on conducting decentralized clinical trials (DCTs) of drugs,...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...
USA – FDA officials offer CMC advice for gene therapies at OTP town hall
Officials from the US Food and Drug Administration’s (FDA) Office of Therapeutic Products (OTP) within the Center for Biologics Evaluation and Research (CBER) urged...
USA – Authorisation for Moderna and Pfizer/BioNTech’s bivalent COVID-19 vaccines simplified by FDA
The current bivalent vaccines, targeting the original and omicron BA.4/BA.5 strains, can now be used for all doses administered to individuals aged six months...
USA – FDA draft guidance aims to help sponsors develop drugs for radiation exposure
The US Food and Drug Administration (FDA) on 19 April issued draft guidance that encourages sponsors to have “early and ongoing” communication with the...
USA – FDA amends COVID vaccine EUAs, considers animal studies to accelerate updates
Monovalent messenger ribonucleic acid (mRNA) COVID vaccines from Moderna and Pfizer/BioNTech are no longer authorized for use in the US, the US Food and...
USA – Global regulators discuss how they are adapting to AI, real-world data in...
Regulators across the globe have been preparing for the arrival of new artificial intelligence (AI) technologies and advances in real-world data (RWD) they say...
