资讯

Pillar Biosciences Receives CMS Coverage for FDA Approved oncoReveal® CDx Pan-Cancer Solid ...
Pillar Biosciences, Inc., the leader in Decision Medicine™, today announced they have received nationwide Medicare coverage ...
Fierce Biotech8 天
Federal judge blocks FDA's regulation of lab-developed tests
A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses ...
JD Supra27 天
FDA’s Backup LDT Enforcement Method: Specimen Collection Kits
We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority to regulate laboratory developed tests ...
来自MSN11 个月
FDA issues final rule regulating LDTs as medical devices
The US Food and Drug Administration (FDA) has issued its Final Rule in officially making explicit that In Vitro diagnostic products (IVD), also known as laboratory-developed tests (LDT), are ...
The Scientist4 年
FDA Lists Bio-Rad’s CFX96 Dx Real-Time PCR System for IVD Testing
The FDA listing extends access to the instrument to assay developers and testing laboratories in the U.S. Throughout the COVID-19 pandemic, the CFX96 Dx Real-Time PCR System has been used by ...
BioWorld20 天
Have kit, will travel further: Telix PET-imaging agent approved by FDA
The U.S. FDA’s approval of Telix Pharmaceuticals Ltd.’s kit for preparing prostate-specific membrane antigen (PSMA)-PET imaging for prostate cancer widens the opportunities to treat patients who live ...
BioWorld20 天
Have kit, will travel further: Telix PET-imaging agent approved by FDA
The U.S. FDA’s approval of Telix Pharmaceuticals Ltd.’s kit for preparing prostate-specific membrane antigen-PET imaging for prostate cancer widens the opportunities for patients who live far away ...