Standards/Regulations

Sep 18, 2013
By BioPharm International Editors
Shamrock Medical Solutions Group, a drug repackaging and distribution company, repeatedly failed to comply with good manufacturing practices.
Sep 17, 2013
By BioPharm International Editors
FDA Issues Draft Guidance on Patient Counseling Info for Labeling
Sep 17, 2013
By BioPharm International Editors
EMA releases details of restructuring.
Sep 12, 2013
By BioPharm International Editors
FDA updates guidance to reflect advances in technology.
Sep 11, 2013
By BioPharm International Editors
The association representing the research-based pharmaceutical industry in Europe is concerned that an EMA policy will put transparency ahead of public-health interests.
Sep 09, 2013
By BioPharm International Editors
Draft guidance recommends in-vitro and in-vivo studies to establish bioequivalence.
Aug 16, 2013
By BioPharm International Editors
CDER withdraws some outdated guidance documents and makes plans to finalize others.
Aug 15, 2013
By BioPharm International Editors
EMA publishes reflection paper on issues regarding the parenteral administration of coated nanomedicines.
Aug 09, 2013
By BioPharm International Editors
FDA receives adverse event reports related to calcium gluconate infusions.
Aug 07, 2013
By BioPharm International Editors
The guidance describes a risk-based approach to monitoring of clinical trials.
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