LAGUNA HILLS, Calif., Jan. 30, 2017 (GLOBE NEWSWIRE) – PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature li...
Blog Archive
Virtual Regulatory Solutions Rebrands as Facet Life Sciences
Innovative Development Solutions Company Rebrands to Reflect Broad Product and Service Offerings Wayne, PA, January 10, 2017 – Virtual Regulatory Solutions, a leading provider of development solutions (software and services) fo...
The Future of Post-Approval Change Management
Reproduced with permission from DIA North America. You can see the original here. By Sarah DeMare, Facet Life Sciences Quality by Design (QbD) was introduced nearly ten years ago as part of FDA’s 21st century quality initiativ...
Electronic Requirement, Are You Ready?
The Food and Drug Administration Safety and Innovation Act (FDASIA) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require that certain submissions under the FD&C Act and the Public Health Service Act be...
PDUFA User Fees- Impact On Your Submission
PDUFA USER FEES – IMPACT ON YOUR SUBMISSION The Prescription Drug User Fee Act (PDUFA) was enacted in 1992 to allow FDA to organize and hire staff with the ultimate desired result of decreased time to an action on the mar...
Orphan Drug Development-Challenges and Incentives
Many of the small pharma companies that VRS supports are developing drugs for rare diseases and conditions. Development of orphan drug (or biologic) products is important to the medical community. “Many diseases appear...
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