As decades of experience have shown, drugs can work very differently in different individuals. Advances in genetic sequencing and genomics made early in the last decade sparked the hope that identifying certain genetic characteristics or biomarkers would yield significant advances in healthcare and give rise to a new era of personalized medicine or, as it is often defined, the practice of administering "the right drug, at the right time, at the right dose, for the right p...

US Food and Drug Administration (FDA) Commissioner Margaret Hamburg recently announced that her agency would soon end a long-standing policy of enforcement discretion toward a classification of diagnostic devices known as laboratory-developed tests (LDTS), but now at least one association has filed a Citizen Petition with the agency seeking to exempt LDTs from new guidance, new regulation or seemingly any regulation whatsoever. Background Under normal circumstances, med...

How do you ensure regulatory compliance in the world's most dangerous laboratory environments? The US Food and Drug Administration (FDA) wants to know, and is proposing to put money behind an initiative it says is aimed at supporting its 'Animal Rule' by developing an academic-based training program to educate pharmaceutical professionals working in high containment environments on good laboratory practices (GLPs). In an advanced posting of an 18 June Federal Register ...

The European Medicines Agency (EMA) adopted a reflection paper that aims to provide quality systems guidance for laboratories in charge of analyzing and evaluating samples generated from clinical trials. Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples , adopted 28 February and released 20 March, intends to provide clinical laboratories "with information that will help them develop and maintain quality systems" that com...