The PDUFA target action date is in the fourth quarter of 2026.
|Articles|May 27, 2004
FDA finalizes donor eligibility criteria for human tissues, cells
The FDA has established donor eligibility criteria for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps) to help prevent the transmission of communicable diseases during transplantation.
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The approval is supported by data from the phase 3 LITESPARK-011 trial.
Pearls & Perspectives: Expanding Sexual Health Conversations Through Digital Media, With Wendy Brant
Amy Pearlman, MD, and Wendy Brant discuss building a digital audience, navigating sexual health content online, and the role of communication in relationships.
Positive safety and efficacy data from 4 clinical studies supported the CE marking.
Sandip Prasad, MD, discusses patient selection for chemoablation in recurrent LG-IR-NMIBC and considerations when counseling patients about a nonsurgical approach.
In a head-to-head RCT, Rezūm produced a 4.6-point greater IPSS improvement than combination pharmacotherapy at 1 year, according to Jean-Nicolas Cornu, MD, PhD, FEBU.
The AACU and the WOCN Society urge CMS to protect access to individualized catheter and ostomy supplies as competitive bidding begins in 2028.
Better detection has changed prostate cancer care. Patients choosing radical treatment still need better protection from the disease returning.
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