The Centre for Cellular and Molecular Platforms – C-CAMP, a Department of Biotechnology - DBT, Government of India initiative recently put together a workshop by the US FDA on 'US FDA Regulatory Process for Anti-microbials'.

This was the first of the programmes planned under the CARB-X Global Accelerator Network, of which C-CAMP is the only accelerator for the Rest of the World (RoW) region i.e. outside of USA and Europe.

The speakers from US-FDA included Dr. Edward Cox, Director of the Office of Antimicrobial Products and Dr. Sumathi Nambiar, Director of the Division of Anti-Infective Products, Office of Antimicrobial Products who spoke extensively on the Regulatory Pathways for approval of Anti-microbial therapeutics and provided information on the role of diagnostics in anti-infective trials. 

“The development of any new anti-bacterial drug is challenging. It is difficult both scientifically and economically. But it is a very important part of drug discovery. We need new drugs since it gets very difficult to keep up with new resistance that keeps coming up. A strategy combining stewardship and science is needed to help combat antimicrobial resistance”, pointed Dr Edward Cox during the workshop.

Meetings between the US FDA Regulators and few start-ups and other companies working in AMR were also arranged as part of the workshop.