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The NHGRI's Advanced DNA Sequencing Technology program is spearheading the development of platforms that will bring routine whole-genome sequencing closer to reality.
Although new botanical drugs pose many challenges for both industry and the FDA, approval of the first botanical prescription drug shows they can be successfully met.
The Minimum Information for Biological and Biomedical Investigations (MIBBI) project aims to foster the coordinated development of minimum-information checklists and provide a resource for those exploring the range of extant checklists.
Vested interests are redefining, rebranding and co-opting what is 'biopharmaceutical'. This is not just a matter of semantics—the core identity of the biotech industry and its products is at stake.
The discovery of a contaminant in batches of heparin throws into stark relief the difficulties, not only for the US Food and Drug Administration, but also for international regulatory agencies, to ensure the safety and quality of active pharmaceutical ingredients.
The heparin safety crisis sends a strong signal that urgent changes in regulatory and manufacturing oversight are needed to ensure the safety of the global drug supply.
Analysis of protein-protein interaction networks is an increasingly popular means to infer biological insight, but is close enough attention being paid to data handling protocols and the degree of bias in the data?