Standards & Regulations

Jun 01, 2013
BioPharm International
Bills to regulate drug compounding and establish a national track and trace system face political and policy differences.
May 30, 2013
By BioPharm International Editors
FDA addresses shortages of drugs needed to treat premature infants and patients unable to eat or drink by mouth.
May 28, 2013
By BioPharm International Editors
Company receives notice from FDA for not fully investigating foreign particles in APIs and finished products from its facility in Ingelheim am Rhein, Germany.
May 14, 2013
By BioPharm International Editors
FDA has released guidance on best practices for conducting and reporting pharmacoepidemiologic safety studies.
May 08, 2013
By BioPharm International Editors
EMA clarifies biosimilars guidelines.
Apr 23, 2013
By BioPharm International Editors
Third compounding pharmacy recalls products due to FDA inspection.
Apr 23, 2013
By BioPharm International Editors
FDA issues draft guidance to minimize medication errors.
Apr 17, 2013
By BioPharm International Editors
FDA has released Guidance for Industry: Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination.
Apr 16, 2013
By BioPharm International Editors
FDA inspections of compounding pharmacies manufacturing sterile-drug products lead to voluntary recalls.
Apr 12, 2013
By BioPharm International Editors
Prefilled-syringe line features automation and novel disinfection techniques.
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