Our healthcare and business law firm often assists provider and medical practice clients with preparing informed consents. Many clients offer treatments in an off-label use and question whether informed consents are necessary for such use. Currently, there is no FDA requirement to get a patient’s informed consent, but it may be beneficial for your practice to implement off-label informed consents. If you have questions about patient consents or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@hamillittle.com. You may also learn more about our law firm by visiting www.hamillittle.com.
What Does “Off Label” Mean?
Off label means providing treatment and prescribing medications for conditions or using a dose different than what the FDA has approved. To become an approved use of a drug or treatment, the FDA must “conduct a careful evaluation of its benefits and risks for that use” and ensure that use “is supported by strong scientific data.” Continue reading ›