FDA

Subscribe to FDA RSS Feed

A Win for Skinny Labels; Insights for Enforcing Use Patents

Most drugs are covered by multiple patents, with initial patents directed broadly to the compound and later patents directed to increasingly narrower uses of the compound. This provides opportunities for the compound to be approved as a generic drug before expiration of all of the patents, based on a “skinny” label – i.e., a label … Continue Reading

Federal Policymakers: Chasing the Runaway AI Train

The U.S. is generally viewed as “behind” in its regulation of AI compared to the European Union and Asian countries. Yet ChatGPT’s release triggered a tsunami of U.S. legislation in 2023 from federal and state legislators seeking to address perceived concerns with the emerging and fast evolving technology. State legislatures have introduced nearly 200 AI … Continue Reading

FDA Proudly Announces Its First Approval of an Interchangeable Biosimilar

On July 28, 2021, the Food and Drug Administration (FDA) announced the approval of the first “interchangeable biosimilar”—in this case Mylan Pharmaceticals Inc.’s Semglee® (insulin glargine-yfgn), which is both biosimilar to, and interchangeable with, its reference product Lantus® (insulin glargine), a long-acting insulin analog. Acting FDA Commissioner Janet Woodcock, M.D. called it a “momentous day.”… Continue Reading
LexBlog