Complying With the DSCSA
Dave DeJean provides his expert insight on lessons he’s learned from his plethora of time in the industry, along with an outlook on where the pharma supply chain stands in adhering to the Drug Supply Chain Security Act (DSCSA).
In this exclusive PC Podcast interview, Dave DeJean, Systech’s VP of global strategic accounts, dives into:
- The valuable lessons he’s learned along the way, given his three and half decades of experience at Systech
- An overview of the Drug Supply Chain Security Act (DSCSA), including its three main pillars
- How he would interpret this “Stabilization Period” that the FDA provided this past summer, and what he pharma industry do now during this period in order to avoid penalties later
- Whether or not he anticipates the FDA implementing any other sort of delays in the near future in order to help remedy these issues/challenges surrounding the enactment of DSCSA
The latest episode of The Pharmaceutical Commerce Podcast is available directly on SoundCloud.
An Exploration of Compounding Practices
May 22nd 2025In a Q&A with Pharma Commerce, Kurt Lunkwitz, ProRx Pharma’s COO, uncovers the stringent requirements that 503B outsourcing facilities must abide by under the Drug Quality and Security Act, while also shedding light on the FDA’s impact when it comes to improving the safety, quality, and trust in compounded drugs.
FDA Outlines Updated Requirement for Placebo-Controlled Trials in Vaccine Research
May 21st 2025In an article recently published by The New England Journal of Medicine, FDA higher-ups Vinay Prasad, MD, MPH; and Martin A. Makary, MD, MPH, wrote that any new COVID-19 vaccine must now be evaluated in placebo-controlled studies.
