Subpart A—General Provisions

Sections

• 601.2
  § 601.2 Applications for biologics licenses; procedures for filing.
• 601.3
  § 601.3 Complete response letter to the applicant.
• 601.4
  § 601.4 Issuance and denial of license.
• 601.5
  § 601.5 Revocation of license.
• 601.6
  § 601.6 Suspension of license.
• 601.7
  § 601.7 Procedure for hearings.
• 601.8
  § 601.8 Publication of revocation.
• 601.9
  § 601.9 Licenses; reissuance.