Top 3 Reasons Why Your Medical Device Needs a Clinical Trial
Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. While drugs
Consulting
FDA Guidance Offers New Flexibility to Biotechs in Cell and Gene Therapy
The Food and Drug Administration (FDA) recently released new guidance regarding cellular and gene therapy products, one of which may
Sickle Cell Disease: The Importance of Amplifying Patient Voices
Having a one in four chance of developing sickle cell disease (SCD) is uniquely, and overwhelmingly, familiar to the African
Is Your Site Ready for an FDA Inspection?
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
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.
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.