JD Supra

Workflow of the Week: Applying Automation to the NDA Process

Draft and send pre-approved NDAs in just a few clicks with workflow automation. Legal managers often find themselves caught in an endless loop of back-and-forth with signatories, painstakingly ...
Regulatory Affairs Professionals Society

FDA issues guidance on sharing potential NDA patent information

The US Food and Drug Administration (FDA) has published draft guidance for applicants for new drug applications (NDAs) and ...

Fayetteville Mayor Molly Rawn institutes policy for NDA approval and retention

Mayor Molly Rawn released a statement Tuesday afternoon outlining the role non-disclosure agreements (NDAs) can play in ...
Nature

The prevalence of post-NDA drug patents and their relationship to the timing of generic approval

Patent applications filed after a New Drug Application (NDA) is approved are uncommon and do not appear to substantially delay approval of generic drugs in most cases ...
Nasdaq

UroGen Submits Completed UGN-102 NDA Seeking Approval as the First FDA-Approved Treatment for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

PRINCETON, N.J.--(BUSINESS WIRE)-- UroGen Pharma Ltd. (Nasdaq: URGN), a leading biotech company specializing in novel therapies for urothelial and specialty cancers, today announced the successful ...