US FDA has 120 days to review generic sponsors’ requests for letters to help them obtain product samples, but will not send them to the reference product company.
The US Food and Drug Administration process to issue letters helping generic sponsors obtain samples of products covered by a Risk Evaluation and Mitigation Strategy is being tweaked as interest in the program remains strong.
Since the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act was enacted in December 2019, the agency has issued 60 Covered Product Authorizations (CPAs) and denied only two....
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.
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.
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.
