Most Viewed Articles - Pharmaceutical Technology

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EMA Finalizes Pharmacovigilance Guidelines

June 28, 2012

ePT--the Electronic Newsletter of Pharmaceutical Technology

The European Medicines Agency has published its first set of finalized guidelines concerning good pharmacovigilance practices.

EMA Investigates Roche for Deficiencies in Safety Reporting

June 28, 2012

ePT--the Electronic Newsletter of Pharmaceutical Technology

The European Medicines Agency has launched an investigation into Roche after an inspection found that thousands of potential safety reports, including 15161 deaths, connected to Roche medicines had not been evaluated to determine whether they should be reported to regulators as adverse drug reactions.

Roche to Close US R&D Site

June 27, 2012

ePT--the Electronic Newsletter of Pharmaceutical Technology

Roche announced that it will be closing its R&D site in Nutley, New Jersey, eliminating approximately 1000 positions.

FDA Updates List of Warning Letters

June 26, 2012

ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA has updated its website to include the latest Warning Letters issued to pharmaceutical companies by the Office of Prescription Drug Promotion and the Center for Drug Evaluation and Research.

Merck Serono Announces Final Restructuring Plan

June 21, 2012

ePT--the Electronic Newsletter of Pharmaceutical Technology

Merck Serono has revealed its final "final efficiency program" for operations in Switzerland, which includes confirmation of the closure of sites in Geneva and Coinsins and their associated job cuts.

A Practical Guide to Pan Coating and Scale-Up

June 20, 2012

Equipment and Processing Report

An understanding of the pan-coating process based on first principles can support successful scale up.

US Government Awards $400 Million in Contracts for Vaccine Manufacturing

June 19, 2012

ePT--the Electronic Newsletter of Pharmaceutical Technology

Novartis, GlaxoSmithKline, and Lonza are among those participating in newly formed consortiums for developing and producing medical countermeasures.

EMA Makes Orphan Drug Recommendations

June 19, 2012

ePT--the Electronic Newsletter of Pharmaceutical Technology

The European Medicines Agency's Committee for Orphan Medicinal Products made recommendations for nine orphan drug designations during its June 2012 meeting. Included in COMP's recommendations were four designation applications for rare forms of lipodystrophy.

Pharma Associations Provide Update on Anticounterfeiting Initiatives

June 11, 2012

ePT--the Electronic Newsletter of Pharmaceutical Technology

European and US associations call for continued vigilance against the threat of counterfeit medicines.

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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
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Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
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