Publications
Risk Management (4)
Product Safety Management
Introduction The risk of accidents and products liability can never be completely eliminated. However, potential liability can be minimized by reducing the probability of accidents...
FDA Requirements for Informed Consent Forms
Obtaining informed consent from participants in a clinical trial study is vital. A key document in the informed consent process is the informed consent form. Food and Drug Administration...
Best Practices for Responding to Form-483s and Warning Letters
Perhaps no enforcement actions are dreaded more by life science companies than FDA Form-483s and Warning Letters. This is not only because these actions put the company on the FDA’s radar...
Changing Times: What Buyers of Legal Services Need to Know Now
If you think you know how corporate legal services are purchased, you might want to take a second look, because the relationship between companies and their lawyers is rapidly...
Off-Label Promotion
Question:What risk management precautions should a firm take if significant sales are derived from off-label use of its drug or device? Answer: Promoting medical devices and...
When is a Drug or Device Misbranded?
The Federal Food, Drug, and Cosmetic Act ("FDCA") is a federal law that is a primary source for many rules that impact the pharmaceutical and medical device industries. The FDCA's intent...
Minimizing Risk When Obtaining Informed Consent
Compliance with FDA regulations is only the first step in minimizing the risk associated with the informed consent process. This article provides an overview of requirements and several...
Improving Recall Effectiveness for Medical Devices
As we all know, recalls can be one of the most costly and damaging events in any manufacturer’s corporate experience. Not only do recalls bear tremendous reputation implications, but they...
Risk Shifting Through Contracts: Meaning & Examples
Abstract: In an increasingly global economy, medical device manufacturers are finding that they must rely more and more on supply chains in order to control costs and successfully compete...
Another Step to Claim Resolution With a Medicare Claimant
Introduction On December 29, 2007, former President George W. Bush signed into law the Medicare, Medicaid and SCHIP Extension Act of 2007, or the MMSEA. The MMSEA amends the Medicare...