Standards & Regulation - BioPharm International

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Standards & Regulation

EMA Works to Speed Up Ebola Treatment

October 20, 2014

The agency recommends that companies developing drugs to treat Ebola apply for orphan drug designation.

Hospira Recalls Certain Lots of Intravenous Products

October 15, 2014

Hospira voluntary recalls certain lots of several LifeCare products due to potential for leakage.

Biopharma Manufacturers Respond to Ebola Crisis

October 1, 2014

Demand for new therapies and vaccines spotlights production challenges.

FDA Releases REMS Report

September 25, 2014

FDA report details risk mitigation projects.

USP Supports WHO Biologics Naming Proposal

September 25, 2014

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

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FDA releases draft guidance on electronic submission of lot distribution reports.

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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