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REGULATORY
- JPO Decides Lipitor Crystal Form “Valid”, Sandoz Calls for Appeal
January 30, 2012
- PAFSC’s First Committee Recommends Approval for Zyprexa for Depression in Bipolar Disorders
January 30, 2012
- MHLW Grants Fast Track Review Status for Applications for Generic Brand Name Change
January 27, 2012
- MHLW Presents New 5-Year Plan to Promote Clinical Trials
January 27, 2012
- CSIMC Recommend Approval for Basic Proposal for FY2012 NHI Pricing; 0.86% Price Cut for Long-Listed Drugs, 0.33% for Generics
January 26, 2012
- NHI Price Reduction Method Changed for Aricept, Flolan
January 26, 2012
- Rule Review in Similar Drug Re-Pricing Yields 50 Exemptions Based on Competitiveness
January 26, 2012
- Correct Dosage, Administration for Lamictal Asked: Pharmaceuticals Safety Info
January 26, 2012
- Companies Should Be Required to File Notifications for Package Inserts: Subcommittee
January 26, 2012
- HSC Subcommittee Approves Revised Ethical GL for Genomics Research
January 26, 2012
- PMDA Considering Review Procedure Policy for IVD Agents Based on FDA Guidance Draft
January 25, 2012
- 16 APIs Including Aricept, Lyrica to Be Re-Priced for Market Expansion
January 25, 2012
- MHLW to Issue Revised Notifications in Preparation for Application to PIC/S
January 25, 2012
- Revised Basic Plan Against Cancer to Include Pediatric Cancer Measures
January 24, 2012
- Senior Vice Minister Tsuji to Actively Support Creation of 3rd-Party Organization
January 23, 2012
- Proposed Amendment of PAL Would Require Submission of Package Inserts: Mr Kikura
January 23, 2012
- Huge Drop in Compliance Rate for “Explanations in Writing” in Sales of Class 1 OTC Drugs: MHLW Undercover Survey
January 20, 2012
- PMDA to Introduce Direct ADR Reporting System for Patients on Trial Basis
January 20, 2012
- Prof. Nakamura of Keio Univ. Sees Orphan Drug Development Strategy as Reason for Revised Re-pricing Policy
January 20, 2012
- EMA Initiates Review of Oral MS Treatment Gilenya Following Reports of Heart Problems
January 20, 2012
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