PAREXEL Consulting Releases New White Paper on FDA's Drug Review Process
Today PAREXEL Consulting (Boston, MA) released its second annual study on the state of the FDA drug review process. Findings are captured in the white paper The Innovation Imperative in the Safety First Era, which answers questions such as:
- How has the increased safety scrutiny at FDA affected new drug review times and outcome patterns?
- If first-cycle NDA approval rates have steadied, why have approval rates for priority NDAs stumbled recently?
- Pending NDAs surged over the last year, but have NME submissions as well?
“The implications of FDAAA and CDER’s implementation of the law have been widely discussed, and there is considerable conjecture in the biopharmaceutical industry regarding how FDA review timelines and the approval process are being impacted by new requirements, such as REMS," said Mark Mathieu, Director of Strategic Research at PAREXEL Consulting and the study’s lead author. "What our research provides is a real-world, metrics-based assessment to help inform expectations of new drug review outcomes in the Safety First Era."
That assessment also includes discussions on real-world implications of overdue NDA reviews on first-cycle approval rates and why priority-rated drugs continue to have advantages in the drug review process, despite their decline.
To find out more, the white paper is available for down load here.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
