Search results
Results from the WOW.Com Content Network
The PDUFA date thus serves as a 'best estimate' of when a decision on a New Drug Application or a Biologics License Application would be forthcoming. This response may be a decision to approve the application or a Complete Response Letter (CRL). The PDUFA date may be extended by the Food and Drug Administration in certain circumstances. [6]
A 2002 U.S. Government Accountability Office (GAO) report found that PDUFA funds allowed the FDA to increase the number of new drug reviewers by 77 percent in the first eight years of the act, and the median approval time for non-priority new drugs dropped from 27 months to 14 months over the same period.
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 Kapit-Bisig Laban sa Kahirapan – Comprehensive and Integrated Delivery of Social Services – National Community-Driven Development Program (Kalahi CIDSS–NCDDP) is the community-driven development program of the Philippine Government implemented through the Department of Social Welfare and Development.
The phrase "PDUFA date" is thrown around frequently when discussing biotech and pharma companies. PDUFA stands for the Prescription Drug User Fee Act, which is a law allowing the Food and Drug ...
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 ...
The Commercial and Government Entity Code, or CAGE Code, is a unique identifier assigned to suppliers to various government or defense agencies, as well as to government agencies themselves and various organizations. CAGE codes provide a standardized method of identifying a given facility at a specific location.
Pursuant to the Executive Order No. 94 of Republic Act No. 52, the President of the Philippines reorganized the different departments, bureaus, offices and agencies of the government of the Republic of the Philippines. Consequently, the Insular Collector of Customs was changed to Collector of Customs for the Port of Manila.