OTHER CONTENT IN THIS STREAM
Q&A: Developing and Labeling of In-vitro Companion Diagnostic Devices for Oncology Products
For a Specific Group or Class of Oncology Products
Root Cause: Why does Regulatory Approval Not Always Equate to Commercial Success?
How New India Clinical Trial Regulations Will Improve Drug Development
FDA Releases a Biopharmaceutical Naming Update
Four Strategies for Capitalizing on China’s New Generic Drug “4+7” Bulk-Buying Rules
FDA Publishes Guidances Aimed at More Inclusive Eligibility Criteria for Cancer Clinical Trials
New Zealand Draft Therapeutics Product Bill: Are You Prepared?
Good Tissue Practices (GTP): A Lesser-Known GxP
Falsified medicine directive EU
CMC readiness remains the major hurdle when conducting cell and gene therapy trials
The State of Germline Gene Editing. What We Don’t Know!
Regulatory Pathway for New Drug Importation into China
FDA Compliance: When Does Electronic Data become a cGMP Record?
Regenerative Medicine versus Regenerative Medicine Therapies versus Regenerative Advanced Therapy, What is the Difference?
Qualification as a Step Toward Assay Validation for CBER Regulated Cell and Gene Therapy Products
How to Successfully Obtain Breakthrough Device Designation
A Harmonized Approach to Data Integrity
Updates on Regenerative Medicine Advanced Therapy (RMAT) Designations
Points to Consider for Manufacturing Biologics at the Clinical Site
Benefits of Identifying Critical Quality Attributes, and Correlating the CQAs with Clinical Outcomes for Biologic Products