• Preclinical pharmacology/toxicology programs to support    Phase I clinical trials
  • Expedited regulatory mechanisms
  • Regulatory strategies to gain competitive advantage
  • Rapid and uninterrupted clinical development
  • Human subjects protection
  • Strategies for combination products
  • Leveraging discovery research
  • Meeting with the FDA



What's new at the Center for Biologics Evaluation and Research (CBER)

Guidance for Industry: S6, Preclinical Safety Evaluation of
Biotechnology-Derived Pharmaceuticals

Guidance for Industry M3, Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals

Asceptic Processing Guidance
Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing
Current Good Manufacturing Practice

Fast Track Guidance
Guidance for Industry Fast Track Drug Development Programs - Designation, Development, and Application Review

Platelet Guidance
Guidance for Industry: for Platelet Testing and Evaluation of Platelet Substitute Products

Blood substitutes
Guidance for Industry: Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Blood Cell Substitutes

Fibrin sealant Guidance
Guidance for Industry: Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use

Institutional Review Boards (IRB)
Office for Human Research Protections (OHRP)

Informed Consent

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