Good Manufacturing Practices: When Do They Apply?
Navigating cGMP application in investigational drugs can be complex. Learn how FDA guidelines help clinical teams maintain safety and quality from early trials to commercialization.
regulatory
The Regulatory Binder Checklist For Clinical Trial Sites
A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents;
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
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
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.
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
Pitfalls of Chemistry, Manufacturing, and Controls in Investigational New Drug Preparation
Developing an investigational new drug (IND) application is a big milestone for organizations, especially small companies bringing their first drug
Keep in Touch: Tips for Working with a Single IRB for the First Time
Recent regulations and policies have ushered in the era of mandated single IRB (sIRB) review. Many institutions must now establish policies and processes for working with an external sIRB.
Q&A – Ask Advarra Live: The Real-World Impact of COVID-19 on Research
Experts from Advarra and Johns Hopkins University School of Medicine provided practical guidance on the COVID-19 research impact in a recent webinar. We’ve addressed the most popular Q&A topics here.
Differentiating “Public” and “Private” Internet Spaces in IRB Review
What is the difference between “public” and “private” internet spaces? This question has gained importance with the growing practice of using internet and social media platforms as a source of research data.
Meeting the Challenges of Investigator-Initiated Trials
Stem cell clinics with unproven treatments are on the rise in the US. Learn how the FDA is working to bring new stem cell therapies under federal oversight.
The Challenge of Unproven Regenerative Stem Cell Therapies
Stem cell clinics with unproven treatments are on the rise in the US. Learn how the FDA is working to bring new stem cell therapies under federal oversight.