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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.
Substance evaluation is carried out under a programme known as the Community Rolling Action Plan . An independent review of progress by national officials published in late 2018 found that 352 substances have so far been prioritised for substance evaluation with 94 completed. For almost half the 94, officials concluded that existing commercial ...
An FDA decision not to grant fast track status, or any other general dispute, may be appealed to the division responsible for reviewing the application within the Center for Drug Evaluation and Research. The drug sponsor can subsequently utilize the Agency's procedures for internal review or dispute resolution if necessary. Once a drug receives ...
Ten years later, with the beginning of the biotechnology revolution, the line between a drug and a biologic, or a device and a biologic, became blurred. [8] It was merged with the FDA's Bureau of Drugs to form the Center for Drugs and Biologics during an agency-wide reorganization under Commissioner Arthur Hayes. [8]
In 2017, the Supreme Court of Canada held that "a DRE is a 'drug recognition expert', certified as such for the purposes of the 12 step evaluation. By reason of his training and experience, a DRE undoubtedly possesses expertise on determining drug impairment that is outside the experience and knowledge of the trier of fact.
The agents found 30 “brick-like” packages weighing a total of 78 pounds containing a “white powdery substance. ... stuffed with $1.1 million worth of cocaine dumped near the border with ...