US FDLI publishes handbook on pharma risk management

Now that the US Food and Drug Administration has new authority to improve the safe use of pharmaceuticals, drug manufacturers can be required to develop comprehensive risk assessment evaluations and restrict their marketing on existing products.

To help drugmakers, consultants and other medicines industry stakeholders prepare and comply with the new rules on risk evaluation and mitigation strategy (REMS) mandated under the FDA's Act Amendments of 2007 (Marketletter July 16, 2007), the Washington DC-based Food and Drug Law Insitute has issued what it describes as "the most complete handbook on risk evaluation and management published to date: Pharmaceutical Risk Management: Practical Applications."

Offers "practical guidance"