Pharmaceutical Technology on MSN
FDA’s commissioner vouchers prompt questions about award process
Despite the FDA’s CNPV scheme generating high interest, the process around how voucher awards are prioritised remains unclear ...
The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
The rejection of Disc Medicine Inc.’s experimental compound for a rare and devastating disorder by the US Food and Drug Administration, just months after it received a voucher intended to speed US ...
The National Academies of Sciences, Engineering, and Medicine are private, nonprofit institutions that provide expert advice on some of the most pressing challenges facing the nation and world. Our ...
Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...
The U.S. Food and Drug Administration will award up to $50 million over five years to the University of North Carolina at Chapel Hill and Duke University to establish the Research Triangle Center of ...
Replacing animal testing with alternate methodologies in preclinical drug trials holds potential for the development of ...
Established drugs were repurposed, “me-too” drugs were approved, and even the few new biological approaches lacked clinical ...
HCB101, a novel Fc-based anti-SIRPα-CD47 fusion protein, has received orphan drug designation (ODD) from the FDA for the ...
FDA grants Breakthrough Device Designation to BioAgilytix’s anti-AAV antibody assay supporting Lexeo’s gene therapy for ...
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