Attorney George F. Indest III AttorneyBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On July 6, 2018, the U.S. Food and Drug Administration (FDA) released draft guidance outlining its recommendations for how drug companies should word the indications and usage sections on a drug’s label. The new guidance aims to increase readability and reduce redundant information on indications and usage.

Drug Indication Label.

Prescribers can expect to see revamped drug labels with clearer descriptions of the conditions and patient populations for which an FDA-approved drug is indicated. Also, described in the guidance are circumstances when it might be appropriate for an indication to be either broader or narrower than the parameters of the clinical studies that backed its approval.

In addition to suggesting what information labels should include, the draft guidance also indicates what should be omitted to avoid unnecessary clutter the label.

The FDA hopes this guidance will give health care providers more precise information on which conditions a drug is approved to treat and, therefore, help identify the correct treatment options for patients. To read the FDA’s draft guidance in full, click here.

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Gever, John. “Drug Labels to Get FDA Revamp.” MedPage Today. (July 6, 2018). Web.

Field, Emily. “FDA Releases Draft Guidance On Drug Indication Labeling.” Law360. (July 6, 2018). Web.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

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