GDUFA Reauthorization: A Primer
To help ensure FDA continues to have sufficient resources to carry out its mission, Congress enacted the first Generic Drug User Fee Amendments (GDUFA) in 2012. GDUFA specifies various fees the agency sets and can collect from manufacturers, such as ANDA applications, Drug Master Files(DMF) and facility and program fees. In turn, the fees aid FDA’s […]
White Paper: Potential Savings from Accelerating U.S. Approval of Complex Generics
by Alex Brill, Founder and CEO, Matrix Global Advisors; Resident Fellow, American Enterprise Institute Accelerating FDA approval for complex generic drugs is an untapped avenue for improving access to low-cost drugs for patients and saving the U.S. billions per year. According to an independent analysis commissioned by Teva Pharmaceuticals, regulatory delays for complex generics cost […]
Complex Generics Could Save the U.S. Health Care System Approximately $1.3 Billion Per Year
New Report Finds Eliminating Approval Delays Could Accelerate Access to Lower-Cost Alternatives WASHINGTON, D.C. (FEBRUARY 9, 2021) – The Association for Accessible Medicines (AAM) today announced the release of an economic analysis that found that delays in the approval of complex generics are costing the U.S. health care system an estimated $1.3 billion each year. […]
AAM Statement in Response to FDA’s Competitive Generic Therapy (CGT) Designation
WASHINGTON DC (August 8, 2018) – “We applaud Commissioner Gottlieb and the FDA for recognizing the critical role generics play in helping to control overall drug costs. Generic manufacturers have responded to the Administration’s efforts to increase competition through the new CGT pathway and remain committed to working to ensure that safe, effective and more […]
