Pharma

Your Article Summary

See Latest Articles

Manufacturers Face New Risk-Management Requirements
Pharmaceutical Technology, 07/23/09

Wechsler W – The abuse and misuse of opioid painkillers is out of control, and the US Food and Drug Administration wants to defuse this serious public–health crisis. Previous risk–mitigation programs have failed to halt the inappropriate use of these drugs, prompting FDA to put more teeth into oversight through the Risk Evaluation and Mitigation Strategies (REMS) program established by the FDA Amendments Act of 2007 (FDAAA). FDA has called on manufacturers and other interested parties to help devise a workable REMS that will ensure continued access to medications essential for patients suffering from chronic pain, but also curb inappropriate prescribing, unintentional overdosing, and intentional abuse.

Today in Regulatory Issues...keeping you current

Receive free subspecialty "5-minute updates" via email

FDA drug approval intervals from 1997 to 2006: analysis and comparison during information technology implementation
International Journal of Electronic Healthcare , 12/01/09

Regulatory Update: GSK files Rotarix for prevention of rotavirus in Japan
GlaxoSmithKline, 12/01/09

Shire Submits European Marketing Authorization Application (MAA) for velaglucerase alfa for the Treatment of Type 1 Gaucher Disease
Shire, 11/30/09

 See all of Regulatory Issues