Tag: Fda guidance

Opzelura (ruxolitinib) is the first FDA-approved topical Janus kinase (JAK) inhibitor for both atopic dermatitis and vitiligo, but the recommended treatment duration varies significantly by condition. For atopic dermatitis, use is typically short-term and intermittent for flare-ups, while vitiligo treatment often requires continuous application over a much longer period.

The U.S. Environmental Protection Agency (EPA) has classified N-nitrosodimethylamine (NDMA) as a probable human carcinogen, based on evidence from animal studies. It is a toxic chemical that has garnered significant public attention due to its detection as an impurity in several common medications, leaving many to wonder what NDMA does to your body.

The FDA issues numerous guidance documents annually to help regulated industries, including those in pharmacology, understand the agency's current thinking. A specific type, a Level 2 FDA guidance, is distinguished by its less complex nature, focusing on existing practices and minor policy adjustments.

With millions using GLP-1 agonists like Ozempic, many have a critical question: **can you take Ozempic while pregnant?** [1.2.1] Medical guidance from the FDA and drug manufacturers is clear that it is not recommended due to potential risks to the fetus [1.2.1, 1.2.2].