CBER Concludes 115 Bioresearch Inspections In FY ’12, Up From 99 In FY ’11
Inspections of clinical investigators constituted the bulk of Center for Biologics Evaluation and Research classified inspections, numbering 84, compared to 62 in the previous fiscal year.
You may also be interested in...
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.
EMD Serono has been tracking Serostim packages since 2002; J&J is using Prezista 600 mg as a trial run for serialization.
Stakeholder meeting will address poor enrollment rates and other issues that undermine the utility of pregnancy registries, as well as the use of alternatives, such as case control studies and claims-based database studies.