REGULATORY

• J-ADNI Data Falsification “Unacceptable” If True: MHLW
  May 28, 2014

• Approval for Remicade Biosimilar Products Reported to PAFSC’s Second Committee
  May 28, 2014

• CRC Training Program Presented to Panel on Clinical Research Promotion
  May 27, 2014

• Diet Enacts Japanese NIH-Related Bills
  May 26, 2014

• MHLW to Discuss Setting Rules on OTC Switching of Diagnostics at Panel on In Vitro Diagnostics
  May 23, 2014

• PAFSC’s First Committee to Review LEO Pharma’s Psoriasis Drug on May 30
  May 22, 2014

• Collaborations with PMDA, Prefectures Crucial in PIC/S: MHLW
  May 22, 2014

• Risk Management Plans for 8 APIs Published Since April 2013; Will Be Required for Approval of New Drugs and Biosimilars Starting October 1, 2014
  May 22, 2014

• Kyowa Kirin Workers’ Clinical Study Misconduct “Utterly Unacceptable”: Minister
  May 21, 2014

• MHLW, MOF, Cabinet Office to Come to Agreement on Once-yearly NHI Price Revision by End May
  May 21, 2014

• Clinical Research Grants Might Fall Due to New JPMA Rule
  May 20, 2014

• PIC/S Committee OKs Japan’s Accession from July 2014
  May 20, 2014

• NCC, NCI of US Ink MOU on Joint Research, Academic Interchanges
  May 20, 2014

• Chuikyo to Discuss Sharp Difference in NHI Prices of Identical Products Tenozet, Viread
  May 16, 2014

• Government Says Xeplion Approval Reasonable
  May 15, 2014

• Chuikyo OKs NHI Price Listing of SGLT-2 Inhibitors, New Point-Based Calculations Adopted from This Time
  May 15, 2014

• MHLW to Report Two Remicade Biosimilars to PAFSC’s Second Committee on Drugs on May 26
  May 15, 2014

• MHLW Sends FPMAJ Details of New Point-Based Calculations for New Drug Pricing
  May 14, 2014

• PIC/S to Discuss Japan’s Accession at Upcoming Meeting in Rome; MHLW Anticipates Formal Approval
  May 14, 2014

• PMDA Raises Caution about Concomitant Use of ACE Inhibitors and ARBs
  May 13, 2014

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