On February 1, 2024, Abeona Therapeutics, Inc. (NASDAQ:ABEO) announced that, as part of the review of the Biologics License Application (BLA) for prademagene zamikeracel (pz-cel; formerly EB-101), the ...
The U.S. FDA’s final guidance for clinical trial inspections conducted under the bioresearch monitoring (BiMo) program seems to deviate little if at all from the 2024 draft, but that is precisely the ...
SuperVision Entertainment, Inc. provides hi tech alternate power systems and environment products. It offers amazing SuperMag technology, which develops electricity from magnetic fields. The company ...
When preparing a submission, organize the following information so that it is readily accessible for CDRH BIMO and investigators. The following information is critical for all PMA applications and for ...
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