4 March 2009 FDA pushes graphics on product labels 26 February 2009 Ignore a form 483 Not wise say FDA January 2009 Integrity in Research to the list Breaking News   CEE could gain from Asia’s reputation for fakes   FDA outlines ‘best practice’ for importers 25 October 2008 The Good News for Biotech New Regulation Opens a New Path to Profitability to the list 17 March 2009 Pharmacopoeias diverging on heavy metals testing 12 January 2009 Federal Agencies Issue Draft Guidance for Industry Good Importer Practices 16 September 2008 FDA Issues Warning Letters to Ranbaxy Laboratories Ltd_, and an Import Alert for Drugs from Two Ranbaxy Plants in India to the list 12 January2009 Federal Agencies Issue Draft Guidance for Industry Good Importer Practices 8 October 2008 FDA CDRH Learn - Webpage for Industry Education 12 August 2008 FDA Warning Letter to the list 12 January2009 Federal Agencies Issue Draft Guidance for Industry Good Importer Practices 31 March 2008 GMP Inspection Results Can No Longer Stay Within Borders 27 March 2008 FDA Identifies First Steps in Requirements for Safety Plans for Certain Drugs and Biologics to the list

Press Releases & Guidances Modernization Act of 1997 - modifications to list of recognized standards to the list February 2009 Guidance for Industry - clinical pharmacology section of labeling - content and format 17 March 2008 GMP an unnecessary burden for excipients, review concludes 14 January 2009 Multinational inspections to the list 13 March 2009 U_S_ FDA-CDRH Draft Guidance for Industry and FDA Staff User Fees and Refunds for Premarket Approval Applications 11 December 2008 FDA - Modifications to Devices Subject to Premarket Approval 11 December 2008 US FDA-CDRH Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process - Guidance for Industry and FDA Staff to the list   FDA Federal Dockets Management System Establishing and Operating an Effective GMP Auditing Program 7 February 2008 EMEA IMPLEMENTATION OF ELECTRONIC-ONLY SUBMISSION AND eCTD - Q&A to the list

About the Editor With some forty years experience in Quality Control, Quality Assurance, and Regulatory Affairs, he has served as Division Head and VP Quality and Regulatory Affairs in several large firms in Israel and the US. Today as Managing Director of Lando Quality Management & Engineering Services, Ltd he assists large and small companies in a wide variety of areas and technologies in establishing and implementing Quality Management Systems. Dr. Lando has been a teacher since his undergraduate days including five years at the Technion graduate program in Quality and Reliability and currently in his sixth year at Ruppin College teaching Quality Management and Applied Statistics to third year Industrial Engineering students. Dr. Lando has published over 60 papers and articles in the professional literature and has presented at domestic and international conferences in Israel, Europe, and the US. He is one of the founding members and a Fellow of the Israel Society for Quality and a Senior member of the American Society for Quality. Other professional activities include membership and chairmanship of Standard Institution of Israel standards committees. Dr. Lando served in the Electronics Corps of the IDF with the rank of Academic Officer (Reserve). He holds Private Pilot’s licenses in Israel and the US and has eleven grandchildren.