Regulatory News Archives 2006

December 2006

Health Canada Publishes Regulations Amending the Food and Drug Regulations (Human Plasma Collected by Plasmapheresis) - SOR/ 2006-353 (27 December 2006)
Lutter Appointed Acting Deputy Commissioner for Policy at US FDA (21 December 2006)
GMP Annex 3 “Manufacture of Radiopharmaceuticals” : Draft revision for public consultation (15 December 2006)
Senate approves Bush pick to lead FDA (11 December 2006)
UK medicines regulator committed to help reduce burdens for industry and improve patient access to medicines (11 December 2006)
US FDA Proposes Expanded Availability of Experimental Drugs; Clarifies Permissible Patient Charges (11 December 2006)
Gottlieb to Leave US FDA 16 January (11 December 2006)
PIC/S Press Release - Includes Information on First PIC/S - Industry Forum (6 December 2006)
Health Canada Publishes Good Manufacturing Practices (GMP) Guideline 2007 Edition (GUIDE-0001) - For Comment
ASTM Publishes E2474-06 Standard Practice For Pharmaceutical Process Design Utilizing Process Analytical Technology (4 December 2006)

November 2006

WHO Pharmaceutical Newsletter No. 5, 2006 (29 November 2006)
Japan - U.S. "Harmonization By Doing" HBD Pilot Program Initiative (28 November 2006)
Famulare Selected as Deputy Director of the CDER Office of Compliance, and Friedman as Director of Division of Manufacturing and Product Quality (27 November 2006)
Drugmakers to pay US FDA to OK Ads (20 November 2006)
Health Canada Publishes Policy on Manufacturing and Compounding Drug Products in Canada (POL-0051) (17 November 2006)
WHO and Partners Accelerate Fight Against Counterfeit Medicines (16 November 2006)
FDA Invites Input on Electronic Submission of Regulatory Information (16 November 2006)
UK's MHRA Publishes Promoting High Standards in Medicines Advertising Regulations: Annual Report September 2005 - 2006 (14 November 2006)
PIC/S Issues Consultation on PIC/S Guide to Good Practices for Preparation of Medicinal Products in Pharmacies (Draft 2) (13 November 2006)
Dr Margaret Chan to be next Director-General of WHO (9 November 2006)
Danish Medicines Agency Publishes Steps Toward Improved Consumer Safety (7 November 2006)

October 2006

MHRA Publishes Annual Report and Accounts 2005/06 (30 October 2006)
US FDA Warned To Watch Nanotech Products For Risks (26 October 2006)
US FDA Global Harmonization Task Force, Study Groups 1, 2, 4, and 5; New Proposed and Final Documents (22 October 2006)
Presentation Explaining Changes To Process US FDA Uses To Prioritize The Review of Generic Drugs (19 October 2006)
Dutch MEB and IGZ enter into an agreement with the US FDA about sharing information (13 October 2006)
UK's MHRA Publishes The Outcomes of Investigations Into Four Complaints About Advertising of Medicines (12 October 2006)
EMEA Releases Template for EU Risk-Management Plans (10 October 2006)
New File System Aims to Improve Generic Drug Review Process (6 October 2006)
US FDA role restored over mail-order drug imports (5 October 2006)
Canada's Therapeutic Products Directorate Releases Strategic Plan 2006-2009 (4 October 2006)

September 2006

US FDA Issues Final Manufacturing Quality Guidance for Drug Industry (29 September 2006)
EMEA Publishes Policy on the Handling of Conflicts of Interests of Management Board and Scientific Committee Members and EMEA Experts (27 September 2006)
Priorities for Implementation of the Paediatric Regulation in Europe (26 September 2006)
US FDA Seen Needing To Fix Post-Market Drug Safety (22 September 2006)
Renowned Ethicist Robert Nelson to Advise US FDA on Pediatric Issues
US FDA Guidance Emphasizes Regulatory Responsibilities of Human Tissue Industry (13 September 2006)
US FDA Publishes Good Review Practices Web Page (12 September 2006)
US Medicare Chief Mark McClellan Resigns (5 September 2006)
US FDA Drafts Regulatory Guidance to Industry and Labs for Group of Medical Tests (5 September 2006)
US FDA Drafts Regulatory Direction to Industry for Active Ingredients Used in Medical Tests (5 September 2006)
The European Medicines Agency (EMEA) website and all EMEA-managed websites have moved to the 'emea.europa.eu' internet domain. Similarly, all e-mail addresses used by the EMEA staff will now have the extension '@emea.europa.eu', instead of '@emea.eu.int'.
US FDA Publishes Compliance Program Guidance Manual: 7342.002 - Inspection of Source Plasma Establishments, Brokers, Testing Laboratories, and Contractors (1 September 2006)

August 2006

FDA Forms Task Force on Human Tissue Safety (30 August 2006)
FDA to Review Regulations That Allow Research Without Informed Consent (29 August 2006)
Health Canada Publishes Advance Notice - Update on the Development of Regulatory Framework for Whole Blood and Blood Components (25 August 2006)
Drug Makers Would Submit Registration and Listing Electronically In US Under Proposed Rule (23 August 2006)
Health Canada Releases of Draft Good Guidance Practices Manual for Comment (18 August 2006)
Canada's Health Minister Clement Announces Joint Declaration of Intent with France (16 August 2006)
Quality Risk Management ICH Q9 Briefing Pack (16 August 2006)
ASTM Revises Standard on PAT Terminology (11 August)
FDA Forms Internal Nanotechnology Task Force (9 August 2006)
FDA Approves Influenza Vaccines for Upcoming Flu Season (2 August 2006)

July 2006

FDA Announces Plan to Strengthen Advisory Committee Processes (24 July 2006)
European Commission prepares for RFID (17 July 2006)
ISPE/PDA Conferences to Examine Guidances for Industry with ICH Think Tank (17 July 2006)
FDA Says Open To More Flexible Clinical Trials (11 July 2006)
Report Faults FDA Post-Approval Study Tracking (10 July 2006)
Revision of PIC/S GMP Guide (6 July 2006)
Chapter 8 of the PIC/S GMP Guide has been revised in parallel with the EU GMP Guide to include references to counterfeinting (paragraphs 8.7 & 8.8). Mistakes in the recently revised Chapter 6 have been corrected (paragraphs 6.23 & 6.25).

June 2006

FDA Celebrates 100 Years of Promoting, Protecting Public Health (30 June 2006)
Fewer FDA warnings to companies, Democrats say (27 June 2006)
Top Court Won't Review Schering Antitrust Case (27 June 2006)
US FDA Announces Initiative to Modernize the Regulation of Clinical Trials and Bioresearch Monitoring (26 June 2006)
Independent Evaluation of US FDA's First Cycle Review Performance -- Retrospective Analysis Final Report
New Measures to Protect Americans from Counterfeit Drugs Announced (9 June 2006)
FDA Strengthens Efforts on Unapproved Rx Drugs (8 June 2006)
US FDA posts Guidance for Industry: Q9 Quality Risk Management (1 June 2006)
FDA Withdraws and Revises Guidances on Chemistry, Manufacturing, and Controls Information (1 June 2006)

May 2006