Additional Requirements Information Transparency: Drug labeling for accelerated approval products must clearly disclose limitations, uncertainties about anticipated clinical benefits, and…
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Virginia Contract Research Organization Co., Ltd.
Founded in Taiwan in 1997, VCRO has expanded to China and the US. Specializing in contract clinical research for new drug development, VCRO excels in regenerative medicine and gene therapy. It is recognized as the most professional and experienced CRO in the Asia-Pacific region.
What we do
Service Scope
VCRO has been in the market for 28 years, providing a complete one-stop service from IND to NDA. From medical affairs, regulatory affairs, clinical operations, data management and statistics, to EDC remote electronic data capture systems and IWRS, VCRO supports a complete service structure with more than 600 case experience and has delivered 54+ US FDA IND and 98+ GCP inspection.
54+ US FDA IND
Cell therapy, CAR-T, LBP, Gene therapy, nucleic acid drugs , miRNA , NCE , 505b2……
News / Events
Breaking News
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U.S. FDA Releases Draft Guidance on Expedited Program for Serious Conditions-Accelerated Approval of Drugs and Biologics (Part 3.)
ConclusionThe Accelerated Approval program accelerates drug reviews for serious or life-threatening conditions by utilizing surrogate or intermediate clinical endpoints. It requires confirmatory trials to validate benefits, including a withdrawal mechanism to manage risks, and encourages collaboration between FDA and sponsors. The guidance emphasizes scientific rigor, external consultation, and continuous refinement to ensure effective and safe…