With state-by-state legalization of cannabis products, comes a surge in purported medical benefits. But caution remains that the interest in cannabinoids will lead to the old “snake oil” type of cure-all claims. The FDA has only approved one product containing CBD, for the treatment of of a specific type of seizures. Warning letters from the
The FDA sent letters to manufacturers of loperamide, a longstanding and commonly used treatment for diarrhea, asking them to change the size of the drug’s packaging to limit the amount of opioid drugs in the package. The agency aims to discontinue the large bottles in which loperamide is often sold to deter its abuse. See
Computer simulations may get a role alongside human testing as part of an effort to bring new medications and medical devices to market more quickly and cheaply. The approval process for medical devices and drugs could incorporate computer modeling and virtual testing in an effort to modernize and streamline the regulatory pathway and make drugs
In an unprecedented move, the FDA today granted accelerated approval to the cancer drug pembrolizumab (Keytruda – Merck & Co) for treatment of any unresectable or metastatic solid tumors associated with the genetic abnormality known as microsatellite instability. It’s the first time the agency approved a cancer treatment or indication that is not for a tumor
