A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
Dyax’s DX-2930, an experimental treatment for hereditary angioedema, has won FDA orphan drug designation. The human monoclonal antibody is designed to inhibit plasma kallikrein to reduce swelling, pain and inflammation associated with the disease, the drugmaker says.
Companies manufacturing and distributing unapproved oxycodone products have 45 days to stop producing the pain meds and 90 days to cease shipping them or risk ramped up FDA enforcement. The agency warning, published in the July 6 Federal Register, covers oral forms of unapproved single-ingredient, immediate-release oxycodone products. Failure to comply could result in seizure, injunction or other judicial or administrative proceedings, the agency said Thursday. Drug Industry Daily