7 Takeaways From the 2021 PDA/FDA Joint Regulatory Conference

Last week marked the 30th PDA/FDA Joint Regulatory Conference. Held virtually, the conference featured a number of enlightening presentations by FDA leaders and pharmaceutical industry representatives spanning all facets of the GMP world. 

Below are some brief highlights from the conference.

1. CDER Director Dr. Patricia Cavazzoni covered how the Center has expanded its drug shortage program to include supply chain surveillance. This includes surveillance of multiple signals along the supply chain.
2. In the wake of the pandemic, firms are working through the technical challenges of virtual inspections, using a variety of digital formats. Presenters from AstraZeneca, Biogen, and Genentech/Roche covered how they addressed these challenges during virtual inspections and audits.
3. While the pandemic has required additional manufacturing capacity due to the need for COVID-19 treatments and vaccines, manufacturing quality remains a top concern for FDA. FDA Office of Pharmaceutical Quality Director Ashley Boam covered CDER’s work in engaging with firms via tools such as the NextGen Portal, streamlined assessments, etc.
4. As the conference was underway, FDA coincidentally released a much anticipated guidance, “Microbiological Quality Considerations in Non-Sterile Drug Manufacturing.” Not surprising, this was brought up during Q&A in a few of the sessions.
5. Director of the CDER Office of Manufacturing Quality Francis Godwin addressed how his Center responded to manufacturing quality issues at facilities manufacturing hand sanitizer.
6. CBER Branch Chief, Biological Drug and Device Compliance Branch Maria Anderson discussed GMP trends from Warning Letters and Untitled Letters issued since last year’s conference. Notably, unapproved human cell and tissue-based products are a concern.
7. CBER Director Dr. Peter Marks discussed the product development process for individualized products, referring to them as “bespoke therapeutics.” Development of these novel products may require new models such as organoids and humanized mice.

To stay on top of the latest information from industry conferences, make it a point to regularly check out our Conference Spotlight section of the site. Redica Systems Senior GMP Quality Expert Jerry Chapman will be covering topics raised during the 2021 PDA/FDA Joint Regulatory Conference in the future.