iii
Table of Contents
Foreword. ..........................................................................................................................................v
A History of Quack Medical Devices............................................................................................1
(January 1983, Medical Device +Diagnostic Industry)
Regulatory Requirements and Resources.....................................................................................9
(July 2000, Regulatory Affairs Focus)
Maggots and Leeches—Are They Medical Devices?. ...............................................................15
(November 2004, Regulatory Affairs Focus)
Nanotechnology. ............................................................................................................................21
(August 2005, Regulatory Affairs Focus)
An Overview of Antibiotic Resistance........................................................................................27
(January 2006, U.S. Pharmacist)
Venoms and Toxins. .......................................................................................................................33
(May 2006, Regulatory Affairs Focus)
A Regulatory Affairs Lifetime Philosophy of Learning............................................................39
(July 2006, Regulatory Affairs Focus)
Medical Foods.................................................................................................................................43
(January 2007, Regulatory Affairs Focus)
Rare Diseases. .................................................................................................................................47
(June 2007, Regulatory Affairs Focus)
Medical Writers. .............................................................................................................................51
(November 2007, Regulatory Affairs Focus)
Maggots, Leeches and Now Honey—Putative Medical Devices?..........................................55
(January 2008, Regulatory Focus)
Rats!..................................................................................................................................................59
(June 2008, Regulatory Focus)
Bacteriophages: Beyond Antibiotics............................................................................................63
(October 2008, U.S. Pharmacist)
Serendipity and Drug Discoveries...............................................................................................69
(December 2008, Regulatory Focus)
FDA Approval of Botanical Drugs...............................................................................................73
(January 2009, Regulatory Focus)
Risk: History, Probability and Management. .............................................................................77
(May 2009, Regulatory Focus)
Table of Contents
Foreword. ..........................................................................................................................................v
A History of Quack Medical Devices............................................................................................1
(January 1983, Medical Device +Diagnostic Industry)
Regulatory Requirements and Resources.....................................................................................9
(July 2000, Regulatory Affairs Focus)
Maggots and Leeches—Are They Medical Devices?. ...............................................................15
(November 2004, Regulatory Affairs Focus)
Nanotechnology. ............................................................................................................................21
(August 2005, Regulatory Affairs Focus)
An Overview of Antibiotic Resistance........................................................................................27
(January 2006, U.S. Pharmacist)
Venoms and Toxins. .......................................................................................................................33
(May 2006, Regulatory Affairs Focus)
A Regulatory Affairs Lifetime Philosophy of Learning............................................................39
(July 2006, Regulatory Affairs Focus)
Medical Foods.................................................................................................................................43
(January 2007, Regulatory Affairs Focus)
Rare Diseases. .................................................................................................................................47
(June 2007, Regulatory Affairs Focus)
Medical Writers. .............................................................................................................................51
(November 2007, Regulatory Affairs Focus)
Maggots, Leeches and Now Honey—Putative Medical Devices?..........................................55
(January 2008, Regulatory Focus)
Rats!..................................................................................................................................................59
(June 2008, Regulatory Focus)
Bacteriophages: Beyond Antibiotics............................................................................................63
(October 2008, U.S. Pharmacist)
Serendipity and Drug Discoveries...............................................................................................69
(December 2008, Regulatory Focus)
FDA Approval of Botanical Drugs...............................................................................................73
(January 2009, Regulatory Focus)
Risk: History, Probability and Management. .............................................................................77
(May 2009, Regulatory Focus)