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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 submitted in electronic format specified by FDA.  On May 15, 2015, FDA published the [click to read the full story]

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 marketing application.  Each sponsor of a New Drug Application (NDA) [click to read the full story]

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 early in life, and a total of 30 percent of children with orphan diseases die before [click to read the full story]