- Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic
- Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring
- Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program
- Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice
- State Petitions for Exemption From Preemption
- Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice
- Certification to Accompany Drug, Biological Product, and Device Applications or Submissions
- Guidance for Industry: Fast Track Drug Development Programs: Designation, Development, and Application Review
- Draft Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff on Meetings with the Office of Orphan Products Development
- Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics
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