Rare and Orphan Diseases in Regulated Development
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
Consulting
Regulatory Trends in Cell and Gene Therapies
As cell and gene therapy advances, the FDA is shaping regulatory trends to streamline approvals, support innovative therapies, and enhance global harmonization.
Setting Yourself up for Success During Investigator-initiated Trials
This eBook outlines Tips and best practices for a successful IIT, Post-approval monitoring and clinical project, and Leveraging industry sponsors.
How the IND 30-day Hold Impacts Clinical Trial Activities
The Food and Drug Administration (FDA) is the federal entity in the U.S. charged with (among other things) “ensur[ing] that
Rare and Orphan Diseases: Choosing a Path to Regulatory Approval and Market Success
Explore regulatory pathways and strategies for bringing rare disease therapies to market, addressing challenges in drug development and pricing.
Regulatory, Clinical, and Quality Considerations for Device Research
In response to a growing demand for faster, approved, and cost-effective medical devices for chronic diseases, medical device manufacturers and
An Evolving Regulatory Environment for Rare and Orphan Diseases
Rare diseases affect fewer than 200,000 people each, totaling around 30 million in the U.S. Orphan drugs face R&D barriers, but FDA support has increased since 1983.
Advarra Trend Report: Current State of Trial Opportunity and Selection
Discover survey findings on trial selection, from cumbersome feasibility questionnaires to improving transparency and site opportunities.
Regulatory Pathways: When to Submit a 505(b)(2) or an ANDA
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
5 Questions to Ask Your Sponsor for DCT Implementation
The pandemic proved decentralized clinical trials (DCTs) can reduce patient burden while delivering quality data in a streamlined environment. In
Regulatory Considerations for Pharmaceutical Product Lifecycle Management
As a pharmaceutical product makes its way through the lifecycle, there are often Food and Drug Administration (FDA) guidelines organizations
Q&A: The IND Journey Phase I – Navigating Success
Advarra experts Sharon Ayd and Leslie Paul answer questions from their webinar, The IND Journey Phase I – Navigating Success.