DRW Monthly
Did you miss an issue of DRW Monthly? Click on a date below to read prior issues of this newsletter:
- December 2006
Review of Joint Regulatory Scheme for Proposed Australia New Zealand Therapeutic Products Authority (ANZTPA)
- January 2007
Regulatory Issues Surrounding Genetic Testing in the US
- February 2007
UK Implementation of the EU Directive on Traditional Herbal Medicinal Products
- March 2007
Taiwan Establishes Successful Orphan Drug Program
- April 2007
Developments in the US-Japan "Harmonization By Doing" (HBD) Initiative
- May 2007
The Czech Republic's Harmonization of its Clinical Research Regulations with the EU CTD
- June 2007
EU Approves Regulation on Advanced Therapy Medicinal Products (ATMPs)
- July 2007
Review of FDA/Health Canada's Pilot Multipurpose Audit Program
- August 2007
Compliance Challenges Malaysia faces with Adverse Drug Reporting
- September 2007
Review of Pharmaceutical Advertising Regulations in Canada
- October 2007
Developments in Human Embryonic Stem Cell Research Regulation in Australia
- November 2007
EMEA Introduces EudraGMP Database
- December 2007
Review of FDA's Generic Initiative for Value and Efficiency (GIVE) Program
- January 2008
Update on India's Medical Device Regulations
- February 2008
A Review of FDA Measures to Improve Advisory Committee Processes
- March 2008
Brazilian Medical Device Import Regulations
- April 2008
International Stem Cell Guidelines to be Drafted to Protect Patients
- May 2008
Impact of FDA's Risk Evaluation and Mitigation Strategy (REMS) Requirements on Drug and Biologics Industry
- June 2008
Revisions to China's Medical Device Regulatory System and Reimbursement Issues Impacting Importers
- July 2008
Health Canada's Progress in Regulating Subsequent Entry Biologics: Draft Guidance Issued in March
- August 2008
Argentina Harmonizes Clinical Trial Regulatory Requirements to Conform with International Best Practices
- September 2008
FDA's Pharmaceutical CGMP Initiative to be Implemented in CDER's Office of Biotechnology Products
- October 2008
UK Human Embryology and Fertilisation Bill Passes in House of Commons
- November 2008
Regulatory Paths to Access Unapproved Medicines and Medical Devices in Australia
- December 2008
US and Vietnam Sign Memorandum of Understanding to Enhance Food and Medical Product Import Safety
- January 2009
Japanese Government Adopts Medical Device Approval Action Program
- February 2009
Czech Republic's Healthcare Reforms Result in Drug Reimbursement and Pricing Debates
- March 2009
UK's National Institute for Health and Clinical Excellence to Accelerate Drug Appraisal Process
- April 2009
EU Adopts Classification, Labeling and Packaging Regulation to Align itself with UN's Globally Harmonized System
- May 2009
FDA's Sentinel Initiative to Track Safety of National Drugs, Biologics and Medical Devices
- June 2009
Health Canada Proposes Reforms to its Investigational Device Testing Regulatory Framework
- July/August 2009
ASEAN Economic Ministers Sign Pharmaceutical Trade Agreement and
Stanford University Researchers Publish Medical Device Product Development Model
- September 2009
EU to Establish Not-for-Profit International Biobank
- October 2009
Singapore Issues Guidance on Biosimilar Product Registration
- November 2009
Navigating Pharmaceutical Product Registration in the Russian Federation
- December 2009
NHMRC Lifts Ban on Clinical Trials Involving Xenotransplantation in Australia
- January 2010
FDA Partners with Industry Stakeholder to Implement Its Medication Safe Use Initiative
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