Regulatory
Don’t Get Caught Off Guard: Inspection Readiness for Sponsors and CROs
Discover strategies for proactively assessing compliance for an FDA Inspection Readiness visit. Address deficiencies and implement corrective actions.
Top 3 Reasons Why Your Medical Device Needs a Clinical Trial
Interpreting evolving regulations for medical devices is a common challenge for emerging biotech companies.
FDA Guidance Offers New Flexibility to Biotechs in Cell and Gene Therapy
FDA recently released new guidance, potentially impacting early-phase cell and gene therapy trials.
Rare and Orphan Diseases: Choosing a Path to Regulatory Approval and Market Success
Explore the regulatory challenges and pathway guidance for sponsors bringing innovative rare and orphan therapies to market.
An Evolving Regulatory Environment for Rare and Orphan Diseases
By 1983, only 38 orphan drugs received FDA approval. Since then, the FDA has significantly changed its approach to rare and orphan diseases.
Regulatory Considerations for Pharmaceutical Product Lifecycle Management
New FDA guidance (ICH q12) applies to pharmaceutical drug substances and products requiring a marketing authorization.
Regulatory Pathways: When to Follow a 505(b)(2) or an ANDA
Critical insights and key considerations for selecting the best regulatory pathway to ensure success for new drug application submissions.
The IND Journey Phase I – Navigating Success
Explore strategies for advancing investigational new drug (IND) submissions and a comprehensive guide through Phase I of the IND journey.
GDPR Implementation Support
Learn how Advarra’s global consulting expertise enabled iSpecimen to implement GDPR with no service interruption to their customers.
Pitfalls of Chemistry, Manufacturing, and Controls in Investigational New Drug Preparation
Submitting an Investigational New Drug (IND) application for the first time? Consider three common CMC pitfalls that may impact submission.
Good Manufacturing Practices (cGMP): When Do They Apply?
When do current Good Manufacturing Practices (cGMP) regulations apply? Read more for FDA expectations for the application of cGMP to investigational drugs:
Keep in Touch: Tips for Working with a Single IRB for the First Time
Recent regulations and policies have many institutions establishing policies and processes for working with an external sIRB. Read more:
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