Standards & Regulations

Oct 01, 2013
BioPharm International
Manufacturing standards are considered key to preventing drug recalls and shortages.
Sep 30, 2013
By BioPharm International Editors
EMA revises HIV treatment guideline.
Sep 30, 2013
By BioPharm International Editors
FDA publishes guidance on ANDA submissions.
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FDA Issues Draft Guidance on Patient Counseling Info for Labeling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Draft guidance recommends in-vitro and in-vivo studies to establish bioequivalence.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CDER withdraws some outdated guidance documents and makes plans to finalize others.
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