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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]
PDUFA was passed in order to shorten the length of time from a manufacturer’s submission of a New Drug Application or a Biologics License Application to an FDA decision approval or licensure. [7] Congress created three kinds of user fees via PDUFA and required that they each make up one-third of the total fees collected.
The Philippines is assigned an international dialing code of +63 by ITU-T. Telephone numbers are fixed at eight digits for area code 02, and seven digits for area codes from 03X to 09X, with area codes fixed at one, two, or three digits (a six-digit system was used until the mid-1990s; four to five digits were used in the countryside). Mobile ...
For years, branded-drug makers have paid for speed at the Food and Drug Administration. In 1992, the Prescription Drug User Fee Act, or PDUFA, established a fee for submitting marketing ...
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.
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 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 site enables you to find more than just reverse lookup names; you can search for addresses, phone numbers and email addresses. BestPeopleFinder gets all its data from official public, state ...