CBER Implements Pre-Clinical Meeting Program For Biologics, Gene Therapy Sponsors
INTERACT program will allow sponsors to ask FDA questions about manufacturing and other technical issues to help streamline development.
You may also be interested in...
Biologics center's director encourages sponsors to invite other regulators to early FDA meetings in effort to scale up markets.
FDA Signals Willingness To Grant Regulatory Flexibility For Cell and Gene Therapy Products In CMC Reviews
US FDA official says that the complexities involved in producing cell and gene therapies necessitate a “new manufacturing paradigm” in evaluating biologics license applications. For such therapies, the agency is willing to grant regulatory flexibility in certain areas of its chemistry, manufacturing and controls review.
Trial protocols, annual reports, and adverse event reports on gene therapies will only go to US FDA under now-finalized amendments, a sign that the product category is maturing and can be regulated like other drugs and biologics.