US FDA Preparing For New 'Combination Product Agreement Meetings'
Cures legislation offers more development certainty for sponsors by allowing informal agreements with the agency on pre- and postmarket issues.
You may also be interested in...
US FDA Oncology, Device Centers Developing Public Diagnostic Standards
Pilot program would get around the ‘one drug, one test’ policy, which has created intellectual property issues.
Could US FDA Move Gene Therapy Regulation To Device Center In Years To Come?
CBER Director Peter Marks said more sophisticated manufacturing expected in the next decade could lead to questions about whether gene therapies should be regulated by his center or CDRH.
PDUFA VII: Will Gene Therapy's Rise Influence Talks?
The Center for Biologics Evaluation and Research may need more fee revenue to add employees to handle the increasing cell and gene therapy workload.