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Regulatory Update

Posted 01 April 2009 | By

  • Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Certifications to Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of the Public Health Service Act, Added By Title VIII of the Food and Drug Administration Amendments Act of 2007
  • Brazilian Law on Pharmaceutical Control (Law No. 11.903, as of 14 Jan 2009, Federal Register 15 January, 2009
  • Argentina: Resolution 102/2009: Creation of the Registry of Clinical Trials with Human Beings, 02 February 2009
  • China: Notification to Publish Regulations of Special Examination and Approval in New Drug Registration (Published 7 January 2009)

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