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Quiz
Article
Dermatology Times Spot Test: July 12, 2025
Author(s):
Key Takeaways
- The FDA's release of over 200 decision letters from 2020-2024 enhances transparency in regulatory processes.
- This initiative provides stakeholders with insights into the FDA's decision-making, potentially influencing future submissions.
Put your dermatology expertise to the test with Dermatology Times’ interactive quiz series!
Dermatology Times presents: Spot Test!
Each week, dive into a series of thought-provoking questions designed to test your understanding of essential topics, trends, and breakthroughs in dermatology.
This week, we’ll focus on recent news from the US FDA, in which the organization announced the publication of more than 200 decision letters from the years 2020 through 2024.1
Read more from Dermatology Times.
Do you have a set of quiz questions to share? Contact editor Emma Andrus at eandrus@mjhlifesciences.com to contribute!
In the FDA’s July 2025 transparency initiative, what type of regulatory document was made publicly available to help clinicians and developers better understand non-approvals and cited deficiencies?
Based on a 2015 FDA analysis cited in the July 2025 news release, what proportion of safety and efficacy concerns mentioned in CRLs were omitted from sponsor communications to the public?significant emotional burden in patients with work-related CHE?
In the FDA’s CRL issued for prademagenezamikeracel (pz-cel) for recessive dystrophic epidermolysis bullosa (RDEB), what critical regulatory component required further validation prior to approval?
References
- FDA embraces radical transparency by publishing complete response letters. News Release. US FDA. Published July 10, 2025. Accessed July 11, 2025. https://www.fda.gov/news-events/press-announcements/fda-embraces-radical-transparency-publishing-complete-response-letters?utm_medium=email&utm_source=govdelivery
- Andrus E. FDA sets PDUFA date, accepts BLA submission for pz-cel in epidermolysis bullosa. News article. Dermatology Times. Published November 12, 2024. Accessed July 11, 2025. https://www.dermatologytimes.com/view/fda-sets-pfuda-date-accepts-bla-submission-for-pz-cel-in-epidermolysis-bullosa
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