Publications
Controlling Your Supply Chain
Question:What lessons can manufacturers learn from the heparin contamination crisis? Answer: Heparin, an injectable drug still in wide use as an anticoagulant (blood thinner),...
International Clinical Trials: Look Before You Leap
Logistical problems and financial pressures prompt many medical technology and life sciences companies to sponsor human clinical trials outside the borders of the United States. As...
Vaccine Injury Compensation Program
The early to mid-1980s was an era of considerable vaccine-related litigation. In response to increasing litigation costs and damage awards, many vaccine manufacturers left the market....
Medical Device Reports (MDRs)
The Food and Drug Administration ("FDA") requires medical device companies to report fatal or serious incidents - or potentially fatal or serious incidents - associated with the use of...
Responding Effectively When Your Life Sciences Product Is Under Attack
Any number and variety of crises can threaten a life sciences company and ultimately interrupt its operations, impact its bottom line, and damage its brand reputation. Perhaps it is the...
What are the best practices for dealing with FDA inspections?
Question: What are the best practices for dealing with FDA inspections? Answer: Many life sciences companies may regard the prospect of an FDA inspection with dread, in part because...
Proactive Document Management for Device Manufacturers – Part 1
Introduction Documents—hard copies and electronic records—are the lifeblood of any corporation. While employees come and go and may change positions within an organization, the design...