What is the difference between approval, authorization, and clearance?

Michael Cooper, RAC, Clinical and Regulatory Affairs Program Manager

These common terms are often used incorrectly.

SARS-CoV-2 Variants


What is the impact of the Delta Variant?

Key Considerations for Scale Up Cell & Gene Therapy

Barrett Fallentine, Director, Product & Process Development

A comparison of two types of cell sources. Key considerations for scale up for cell and gene therapy.

Forced Degradation

Brian Glass, Senior Analytical Consultant

Regulations mandate that methods for analysis of drug substance and drug product are stability indicators.

Considerations for CDMO Selection

Barrett Fallentine, Director, Product & Process Development

When considering a CDMO partner keep in mind your future needs.

Navigating the FDA’s Emergency Use Authorization Process

Bikash Chatterjee, Chief Executive Officer

A graphic representation of the FDA’s Emergency Use Authorization Process.

Best Practices for Creating Submission Ready Documents

Barrett Fallentine, Director, Product and Process Development

Instituting good documentation policies early on when developing your biologic drug product can save time and distress when putting together your regulatory submissions.

The Art of the Analytical Method

Emily Sudhyadhom, Senior Analytical Chemist

Analytical Methods should not be the gatekeeper to getting your product to market. Avoiding common pitfalls in development can prevent this.

Important Factors in Regulatory Compliance for Regenerative Medicine Products

Caitlin Bancroft, Senior Regulatory Affairs Specialist

Regenerative medicine products have unique sensitivities when it comes to regulatory compliance in terms of donor eligibility and Good Tissue Practices