Standards & Regulations

Aug 06, 2013
By BioPharm International Editors
A proposed new guideline provides a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients.
Aug 02, 2013
By BioPharm International Editors
EMA releases concept paper on development of product-specific guidance on demonstration of bioequivalence.
Aug 02, 2013
By BioPharm International Editors
EMA restructures organization.
Aug 02, 2013
By BioPharm International Editors
FDA releases FY 2014 generic-drug user fees.
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 23, 2013
BioPharm International
By BioPharm International Editors
Susan Schniepp, vice-president of quality and regulatory affairs at Allergy Laboratories and co-chair of the program planning committee for the 2013 PDA/FDA Joint Regulatory Conference, discusses quality systems and related considerations in parenteral drug manufacturing.
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.
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