Platinum Biologics LLC – 705090

Delivery Method: Via UPS and EMAIL Reference #: CBER 25-705090 Product: Biologics Recipient: Recipient Name Beeben Russell Recipient Title Chairman of the Board Platinum Biologics LLC 1510 E Colonial Drive, Suite 103Orlando, FL 32803United States...

Division of Oncology 2 (DO2)

The Division of Oncology 2 (DO2) regulates Investigational New Drug Applications (INDs), New Drug Applications (NDAs) and Biologic Licensing Applications (BLAs) for the following therapeutic areas: Thoracic Head & neck, Neuro-oncology Rare cancers, Pediatric...

Guidance Documents for Drug Applications

Guidance documents represent the Agency’s current thinking on a particular subject. These documents are prepared for FDA review staff and applicants/sponsors to provide guidelines to the processing, content, and evaluation/approval of applications and also to...