FDA Grand Rounds
Highlights monthly webcast presentations for CE credit by FDA scientists from across agency on their cutting-edge scientific research
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Epigenetic Profiling Identifies Biomarkers Predicting Resistance to AR-Targeted Therapy in mCRPC – Wilbert Zwart
Wilbert Zwart joins Neeraj Agarwal to discuss research on epigenetic targeting in prostate cancer. The discussion examines histone markers in metastatic castration-resistant prostate cancer (mCRPC)…
Study of Sex Differences in the Clinical Evaluation of Medical Product
This guidance provides recommendations for increasing enrollment of females in clinical trials.
Considerations for Including Tissue Biopsies in Clinical Trials
Considerations for Including Tissue Biopsies in Clinical Trials; Guidance for Industry, Investigators, Institutions, and Institutional Review Boards
Guidance on Food Allergen Labeling (Edition 5)
The guidance explains, using a question and answer format, FDA’s current thinking on a number of issues related to the regulation of food allergens, including…
FDA Issues Draft Guidance on Including Tissue Biopsies in Clinical Trials
The FDA issued a draft guidance that, when finalized, will provide recommendations for including tissue biopsies as part of clinical trials evaluating investiga
How healthcare became UPS’ $20B lifeline
UPS Healthcare was a $10 billion business at the end of 2023, accounting for about one-tenth of total revenue. The company aims to double that…
FDA Proposes Framework to Advance Credibility of AI Models Used for Drug and Biological Product Submissions
The FDA issued draft guidance to provide recommendations on the use of artificial intelligence intended to support a regulatory decision about a drug or biologi
FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled Medical Devices
FDA issued draft guidance that includes recommendations to support development and marketing of safe and effective AI-enabled devices
CaboPoint Trial: Cabozantinib in Second-Line RCC Treatment – Laurence Albiges
Zachary Klaassen interviews Laurence Albiges about the CaboPoint Phase II Trial. Dr. Albiges discusses the evolving landscape of second-line treatment for clear cell renal cell…
Pharmalittle: We’re reading about Novo and GLP-1 compounding, Paxlovid and long Covid, and more
Novo Nordisk filed another petition with the FDA seeking to block compounding pharmacies from making versions of one of its GLP-1 drugs
