On 30 September, the FDA issued its first draft guidance on risk evaluation and mitigation strategies for pharmaceutical products linked to serious adverse events. Dow Jones Newswires reported that companies can be fined up to $10 million for noncompliance.

Titled Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications, the guidance document can be found online at www.fda.gov/downloads/Drugs/complianceRegulatoryInformation/Guidances/UCM184128.pdf.

An FDA news release highlights its main points:

• provides the agency's current thinking on the format and content that industry should use for submissions of proposed REMS

• describes each potential element

• includes preliminary information on the content of assessments and proposed modifications of approved REMS

• describes REMS policies for certain regulatory situations

• informs industry about who to contact within FDA about a REMS

• indicates FDA websites where documents about approved REMS will be posted

• provides an example of what an approved REMS might look like for a fictitious product.

Future draft guidances will address additional REMS topics.