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.
You may also be interested in...
Agency officials determining needs using existing budgets before requesting more funds and will engage with tech investors for design advice.
CDER-based program lead by Marta Sokolowska will also handle benzodiazepine and stimulants activities and consult on relevant application assessments.
President Trump's budget request would boost compounding and vaccines by $5m, but human drugs program would lose $4.8m in training funds.