Blogs

In separate moves, regulators in the both the US and Europe have issued documents regarding the role of personalization in the development of new medicines and are seeking public comments. The US Food and Drug Administration (FDA) this week issued a draft guidance proposing that targeted drugs or therapies seeking FDA approval would have to be reviewed simultaneously with their companion diagnostic devices. The draft is open for comment through 12 September. Meanwhile, the European Medicines Agency (EMA) has issued a reflection paper on genomic markers in the development of new drugs. The paper examines the role DNA markers can play in predicting which patients respond to new medications and selecting patients for inclusion in clinical trials. The EMA paper is open for comment until 25 November.

Read more:

• FDA proposes targeted drug testing guidelines (Reuters)
• Pharma regulators consult on drug development initiatives (InPharm)
• Draft Guidance for Industry and Food and Drug Administration Staff - In Vitro Companion Diagnostic Devices (FDA.gov)
• European Medicines Agency seeks views on genomic markers in medicine development (EMA press release)