By conducting a product development or pre-submission meeting, sponsors can receive a mid-review cycle meeting for a complex product ANDA.
Developers of complex generics will gain additional communication rewards if they follow FDA's formal meeting pathway.
Newly released guidance on formal meetings for complex product ANDAs outlines how and when product development, pre-submission, and mid-review cycle meetings are available. But it appears that the first two...
The new system is another step in what could be called the "new drug-ization" of the generic drug development process. FDA Commissioner Scott Gottlieb said in a blog...
Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.
Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.
Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.
Viatris joined Hikma and Amneal, in signing agreements for cash settlements that resolve allegations its practices fueled the US’ deadly opioid epidemic.
