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Specifically, they said Congress only intended user fees to be paid on new indications for a new active ingredient and that switching a drug to over-the-counter status was an exception to the rule requiring user fees. [10] In February 2007 the FDA exempted drugs used in the President's Emergency Plan for AIDS Relief (PEPFAR) from user fees in ...
FDA Amendments Act of 2007: Added two types of annual fees: establishment registration fee and product fee 2012: MDUFA III: Safety and Innovation Act of 2012: Expanded the definition of establishments subject to a registration fee, thus increasing the applicable device establishments paying the fee. 2017: MDUFA IV: FDA Reauthorization Act of 2017
Prior to the Prescription Drug User Fee Act (PDUFA), median approval times of New Drug Applications ranged between 21 and 29 months. [2] The Prescription Drug User Fee Act was first passed in 1992 to facilitate the funding of the Food and Drug Administration while ensuring a more predictable timetable for drug approvals. [3]
The Food and Drug Administration is proposing a revamp of its regulations of medical devices, according to a report it released Wednesday. While seeking to improve device safety, the FDA also ...
In 2011 and 2012, GPhA and the U.S. Food and Drug Administration negotiated the Generic Drug User Fee Act (GDUFA), which requires manufacturers of generic prescription drugs to pay application fees when submitting Abbreviated New Drug Applications (ANDAs) seeking approval for generic products. [10]
It also reauthorizes the Prescription Drug User Fee Act. The PFUDA was first enacted in 1992 to allow the FDA to collect application fees from pharmaceutical companies when applying for approval for a drug. Since then, it has been reauthorized three times; first in 1997, then 2002, and most recently with the passage of the FDAAA in 2007.
Medical Device User Fee and Modernization Act; Medicare Access and CHIP Reauthorization Act of 2015; Medicare and Medicaid Extenders Act of 2010; Medicare Improvements for Patients and Providers Act of 2008; Medicare Prescription Drug, Improvement, and Modernization Act; Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999
The FDA's generic count does not include biosimilars, which are more complicated medicines to review. According to the Generic Pharmaceutical Association, the median time it takes for the FDA to approve a generic is 47 months. [88] On July 9, 2012, Generic Drug User Fee Amendments of 2012 (GDUFA) was signed into law. [89]