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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.
List of initialisms, acronyms ("a word made from parts of the full name's words, pronounceable"), and other abbreviations used by the government and the military of the Philippines. Note that this list is intended to be specific to the Philippine government and military—other nations will have their own acronyms.
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 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.
This is a list of acronyms in the Philippines. [1] They are widely used in different sectors of Philippine society. Often acronyms are utilized to shorten the name of an institution or a company.
Department Native name Seal Formed Head Title Titleholder Portrait Department of Agrarian Reform: Kagawaran ng Repormang Pangsaka: September 10, 1971; 53 years ago () ...
The government of the Philippines (Filipino: Pamahalaan ng Pilipinas) has three interdependent branches: the legislative, executive, and judicial branches.The Philippines is governed as a unitary state under a presidential representative and democratic constitutional republic in which the president functions as both the head of state and the head of government of the country within a pluriform ...