Regulator Spotlight
At the DIA/FDA Oligonucleotide-Based Therapeutics Conference, held in Washington DC in October 2024, CBER’s Office of Therapeutic Products (OTP) Biological Reviewer Eric Levenson discussed considerations for determining the critical quality attributes and specifications for mRNA therapies. He reviewed: ● the regulatory status of mRNA vaccines and therapeutics ● CMC considerations, including in-process and release testing and stability studies across the diversity of mRNA product types, and ● new draft potency guidance for CGTs.
CLICK HERE to view the issue.
ABOUT THE WEEKLY SUPPLEMENT
Along with a feature story on a presentation or panel discussion at a recent conference in which leading regulators address the challenges and developments in a key area of concern, our Weekly Supplements include a summary listing of the “Updates in Brief,” drug GMP warning letters and recalls, and EMA non-compliance reports that have been posted on IPQ’s website during the week. Subscribers can then click through to the full posting.
Also provided, where applicable, are links to the parts of in-depth stories and Monthly Updates that have been released during the week.
Appended to the issue is a chronological listing of the headlines of the featured regulator stories since IPQ began its Weekly Supplement series in February 2024. Also appended are the headlines of the in-depth stories that IPQ has released since 2020. Those of especially high relevance to the regulator insights provided in this issue are indicated with a red star. Click on the headlines to access the stories.