December 2017 FDA Drug / Medical Device Activity

We would like to highlight one of the Draft Guidance issued by the FDA this month.**The U.S. Food and Drug Administration proposed a new, risk-based enforcement approach to drug products labeled as homeopathic. This proposed new approach would update the FDA’s existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices. Under the law, homeopathic drug products are subject to the same requirements related to approval, adulteration and misbranding as any other drug product.

With the new drug listing regulation, all companies have been given a renewed opportunity to ensure their listings are complete and accurate. This includes the label uploaded to the drug listing. The FDA recently issued a warning letter to a company whose listing did not match the product in commercial distribution. Do keep in mind that the FDA requires all changes to a drug listing to be reported as soon as possible but no later than the June or December following the change. As of FDA FY 2018, all drug listings must be certified as accurate by 31 December of each year. Any listing that has not been updated or certified as accurate according to the regulation will be considered expired by the FDA in January of the following year.

Guidance Document updates on the FDA website:

CDER:

CDHR:

CBER:

CDRH and CBER:

Posted in 2018 January, Drug and Device Corner.