FDA REBIF BLA 103780 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for REBIF, BLA 103780. The package contains 29 FDA documents totaling 673 pages, organized by original application and supplemental submission.

Research-ready collection with the FDA documents preserved as individual PDFs and organized by regulatory submission.

What's included

• Original FDA approval records
• 14 supplemental submissions represented
• 1 FDA review document
• 13 approval letters
• 15 labeling documents
• FOIAdocs document index and detailed manifest

Package format: Organized ZIP collection with individual FDA PDFs grouped by regulatory submission, plus a FOIAdocs document index and manifest.

Application: BLA 103780
Product: REBIF
Sponsor: SERONO INC
Documents: 29
Pages: 673
Coverage: Original approval + 14 supplemental submissions represented