United States: FDA Announced That The Following Collections Have Been Submitted To OMB

• 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• Draft Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff on Meetings with the Office of Orphan Products Development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

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.