Pharmaceutical & Medical Device Regulatory Update, Vol. IV, Issue 1

FDA Delays Effective Date of Amended Regulations Affecting "Intended Use" Definition 
The Continuing Story of Manufacturers' Off-Label Promotion of Approved or Cleared Medical Products
Cures Corner: FDA Launches Regenerative Medicine Advanced Therapy Designation Program
President Trump Proposes Dr. Scott Gottlieb as FDA Commissioner 
Ten Years of Conditional Marketing Authorizations 
EMA Consultation on the Revised Policy on Access to Documents 
GCP Renovation ICH Reflection on "GCP Renovation"

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