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The PDUFA date serves as a good first approximation of when a final decision on drug approval can be expected. Sponsors frequently publish PDUFA dates for their pending applications, [1] and while there is no official list of PDUFA dates, [10] several websites collect PDUFA dates from press announcements in a calendar form. [11]
During the eight years before PDUFA took effect, an average of 24 new drugs were approved each year. The number of approvals ranged from 20 in 1988 to 30 in 1991. During the four years that PDUFA I was in effect, an average of 32 drugs were approved each year, ranging from 22 in 1994 to 53 in 1996.
Amazing. Absolutely amazing. The Prescription Drug and User Fee Act, commonly referred to as PDUFA, was set to expire in September, but rather than wait to the last minute, amidst the debt ceiling ...
The FDA approval machinery worked overtime in May, with several new labelings, original approvals and new molecule approvals coming through in the month. The month saw the approval of two new ...
The Prescription Drug User Fee Act, or PDUFA, was arguably lawmakers' greatest gift to drugmakers and their investors. Before PDUFA was enacted in 1992, reviews of marketing applications were long ...
It requires the FDA to develop standards to secure the drug supply chain against counterfeit, diverted, substandard, adulterated, misbranded, or expired drugs, to prioritize and develop standards for the identification and validation of prescription drugs, to develop a standardized numerical identifier for prescription drugs, and to expand ...
The busy calendar of June proved positive for drug approvals, with most scheduled events producing positive outcomes. New molecular entity, or NME, approval for the month totaled two, taking the ...
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