Off-label Drug and Device Applications: Meeting the Challenge

Off-Label Drug Information

drug into interstate commerce unless the FDA has approved the drug and its label.2 A second provision prohibits manufacturers from introducing misbrandeddrugs into interstate commerce.2 Misbranding is considered to occur if drug labeling contains information that describes unapproved uses or is misleading or insufficient to support safe use for approved indications.2 Materials are considered pa...

Meeting the Challenge of Diabetes in China

China’s estimated 114 million people with diabetes pose a massive challenge for China’s health policy-makers who have significantly extended health insurance coverage over the past decade. What China is doing now, what it has achieved, and what remains to be done should be of interest to health policy-makers, worldwide. We identify the challenges posed by China’s two pr...

Hidden truth: The perils and protection of off-label drug and medical device promotion.

What can you do if you learn you have a life-threatening illness but there is no Food and Drug Administration-approved medicine to treat it? Sometimes, there is nothing to do but hope. Very often, though, your doctor will be able to prescribe a drug or medical device that has been approved by the Food and Drug Administration (FDA) for a different condition. This practice, called “off-label” pre...

Prohibition against off-label drug promotion challenged.

Off-label drug use: author's reply.

The authors have stated that the accuracy of dose was checked from standard neonatal formularies, viz. British National Formulary 2005 and Neofax 2008, and stated that 75% of medications were not approved by FDA for neonatal use. They have not mentioned the document or the source that they relied upon to classify the drug as off-label or otherwise. It may not be advisable to decide if use of a ...