The US Food and Drug Administration (FDA) on Wednesday released final guidance for sponsors on when a standard release test and criteria may be used in lieu of extensive method development and ...
The US Food and Drug Administration (FDA) finalized two guidances on studies on 28 May to assist sponsors in establishing bioequivalence (BE) for new and generic drugs. One focuses on BE studies with ...
Alcohol and other drug use is a major problem in Australian workplaces costing more than A$4 billion a year. Of this, $3.6 billion is due to absenteeism. While testing is legal to ensure the health ...
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