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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.
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.
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 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 ...
A.P. Pharma Announces PDUFA Action Date for APF530 New Drug Application Resubmission REDWOOD CITY, Calif.--(BUSINESS WIRE)-- A.P. Pharma, Inc. (OTCBB: APPA), a specialty pharmaceutical company ...
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 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 ...