by Prakash Achaary | Nov 30, 2022 | Blog
Patient safety remains at the forefront of the FDA’s intentions to continue and enhance existing drug safety programs and develop new ones under PDUFA VII. Commitment to Enhanced Communication on Risk Management Activities During Review Some of the planned...
by Prakash Achaary | Mar 14, 2019 | Blog
Exerpt from whitepaper originally published by PhUSE on March 14, 2019 by project co-leads – Rashmi Dodia, MS, RAC and Gregory Campbell, BS Executive Summary Ever since policy 0070 was first introduced in 2016, there have been continuing concerns and challenges among...
by Prakash Achaary | Feb 7, 2019 | Blog
In this Expert Insights interview, we sit down with Jeffrey Wiese, Senior Safety Writer at MMS – to discuss safety writing in the pharmaceutical industry, pharmacovigilance, Risk Evaluation and Mitigation Strategies (REMS), and his future vision. In January 2019, Jeff...
