Standards & Regulations

May 15, 2017
BioPharm International eBooks
BioPharm International speaks with a CMO to find out how it is coping with capacity challenges, regulatory authority scrutiny, supply chain reliability, and new requests from clients to incorporate continuous manufacturing into processing lines.
May 09, 2017
By BioPharm International Editors
FDA sent a warning letter to Pharmaceutic Labs, LLC for deficiencies in producing sterile drugs.
May 09, 2017
By BioPharm International Editors
The agency released its report on pilot project to involve patients in the assessment of medicines.
May 09, 2017
FDA hopes to better use global resources and avoid duplicate inspections of foreign facilities.
May 05, 2017
By BioPharm International Editors
The agency sent a warning letter to Sal Pharma for not disclosing information about API manufacturers to customers.
May 01, 2017
By BioPharm International Editors
The agency has issued more than 90 warning letters over the past 10 years to companies selling fraudulent cancer treatments.
May 01, 2017
BioPharm International
By BioPharm International Editors
Siegfried Schmitt, PhD, Principal Consultant at PAREXEL, discusses how to gain benefits from interactions with industry associations.
May 01, 2017
BioPharm International
Recent legislation and PDUFA initiatives aim to streamline oversight and testing requirements.
Apr 28, 2017
By BioPharm International Editors
The agency met with EU National Competent Authorities to begin making plans for the distribution of workload because of the UK’s departure from the EU.
Apr 27, 2017
By BioPharm International Editors
European Immunization Week promotes the use of vaccines to prevent disease.
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