Drugs that are on the market but are not approved by the FDA are more common than you might think. Even some physicians might be unaware that the drug they are prescribing has not been approved, meaning it has not undergone the rigorous standards of
For years FDA has threatened to remove unapproved products (so-called DESI products) from the marketplace. Recently, the FDA took enforcement action against several unapproved prescription ear drops. What products will be next? DESI producers can use the 505(b)(2) pathway to avoid such actions on their products. Let’s take a
Drug shortages can have serious and immediate effects on providing needed therapies to patients, and preventing shortages is a current priority for FDA. FDA has taken a variety of actions to eliminate, mitigate, and prevent shortages (Executive Order 13588; Interim Final Rule; and Draft Guidance
When Premier Consulting was young, products approved under 505j were called “generics” and 505(b)(1) “new drugs.” There was no consensus name for products approved via 505(b)(2). Of course, at the time there had been very few 505(b)(2) products approved. By now, we have seen an
The FDA is moving against DESI drugs and DESI producers are wondering if their products are next on the chopping block. Here are a few commonly asked questions about how that will affect DESI producers. Will a 505(b)(2) of a DESI receive exclusivity? Yes, the
DESI drugs are a great source for 505(b)(2) development since many will qualify for 5 years data exclusivity. In this post, we will define what they are. Once upon a time…. In 1938 the FD&C Act was established that required that drugs be proven safe
