Standards & Regulations

Aug 01, 2013
BioPharm International
FDA funds research to further development of innovative generics, while working to address review and approval issues.
Aug 01, 2013
BioPharm International
Industry players brace themselves to face challenges as India's new drug-pricing policy kicks in full gear.
Aug 01, 2013
BioPharm International
Nanomedicines have been authorized by European licensing agencies for more than 30 years but are still posing regulatory difficulties.
Jul 02, 2013
By BioPharm International Editors
Programs assist in the fast track of drugs for serious conditions.
Jul 02, 2013
By BioPharm International Editors
Europe prepares for inclusion of Croatia in EMA activities.
Jul 02, 2013
By BioPharm International Editors
Falsified Medicines Directive requires imported APIs to have written confirmation of GMP standards.
Jun 12, 2013
By BioPharm International Editors
ISPE study reveals quality systems of manufacturing as the leading cause of drug shortages.
Jun 11, 2013
By BioPharm International Editors
FDA cites cGMP violations of finished pharmaceuticals at the company's facilities in Marion North Carolina and Jayuya, Puerto Rico.
Jun 11, 2013
By BioPharm International Editors
USP appoints regulatory experts to elemental impurities implementation advisory group.
Jun 11, 2013
By BioPharm International Editors
EMA?s revised guideline on biosimilars containing biotechnology-derived proteins is published for public consultation.
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