US FDA also refused to receive many priority generic drug applications, suggesting the expedited pathway may not be working as intended quite yet.
The US FDA did not approve any priority assessment ANDAs in fiscal year 2018, but did push a few applications through another expedited pathway, signaling that industry may not fully understand the new system intended to help speed generic drugs to market.
Priority assessments were introduced in 2017 as part of the FDA Reauthorization Act. Under the pathway, sponsors can receive an eight-month assessment goal, as opposed to a 10-month standard goal.
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.
Viatris joined Hikma and Amneal, in signing agreements for cash settlements that resolve allegations its practices fueled the US’ deadly opioid epidemic.
The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
