Standards & Regulation - BioPharm International


Standards & Regulation

Biopharma Manufacturers Respond to Ebola Crisis

October 1, 2014

Demand for new therapies and vaccines spotlights production challenges.

USP Supports WHO Biologics Naming Proposal

September 25, 2014

USP expresses its support for a consensus-based global approach to the naming of biologics.

FDA Releases REMS Report

September 25, 2014

FDA report details risk mitigation projects.

GPhA Supports Restricted Access Bill

September 18, 2014

GPhA throws its support behind a bill to prohibit companies from using REMS practices to deter competition.

European Commission Approves RoACTEMRA for Treatment of RA

September 9, 2014

Roche?s RoACTEMRA receives EU approval for use in patients with early rheumatoid arthritis.

FDA Releases Guidance Electronic Submission of Lot Distribution Reports

September 5, 2014

FDA releases draft guidance on electronic submission of lot distribution reports.

Data Integrity Key to GMP Compliance

September 1, 2014

FDA demands accurate manufacturing and test information to ensure product quality.

Extending the Scope of Pharmacovigilance Comes at a Price

September 1, 2014

As the pharmacovigilance infrastructure becomes more entrenched in Europe, drug manufacturers are beginning to feel the burden of its high cost.

The Relevance of Industry Technical Associations

September 1, 2014

Industry associations play a strong role in helping the pharmaceutical industry meet challenges.



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