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May 13, 2012
During the past two years, FDA has been looking more closely at enforcing Part 11 of the Title 21 Code of Federal Regulations regarding electronic records and signatures (see back story).
The potential of single-cell genomics took a step forward recently with the announcement by The Broad Institute and Fluidigm Corporation of a new research center focused on developing research methods and discoveries in mammalian single-cell genomics.
May 09, 2012
More than a year has passed since the FDA issued its guidance, “Process Validation: General Principles and Practices,”.
May 08, 2012
The world of drug development is littered with early-phase failures: drugs that were shown to be safe in Phase I trials, but which failed to show efficacy later on.
May 07, 2012
The pricetag of pharmaceuticals are coming under increasing scrutiny in today’s age of cost constraints.
FDA’s Lucinda Buhse has been spearheading the agency’s spectral library of excipients as a means to improving supply chain security of the pharma industry, particularly focused on raw materials entering US borders (there are 300 entry points in total).
May 06, 2012
Drug shortages, particularly those for sterile injectable drugs, took center stage last year. In response, industry and the federal government, including FDA,
May 02, 2012
Industry, the public sector, and individuals can play an important role in creating solutions.
In attending the exhibitions and conference sessions at Interphex 2012 this week in New York, we gain a pulse on the current and future state of pharmaceutical manufacturing.
May 01, 2012
Jim Miller of PharmSource gave a keynote talk this week at Interphex 2012 in New York City on the state of the industry’s outsourcing environment.