Trying to Rally PGx, CDER s Woodcock Solicits Trust Between Pharma, FDA | GenomeWeb

Pharma and the Food and Drug Administration are stuck in a stalemate over pharmacogenomics. Determined to put pharmacogenomics technologies to use in drug discovery, the FDA, desperate for edification, has asked pharma to submit voluntarily certain genotyping and gene-expression data.

But pharmas, fearing these data may reappear downstream to bite them on the bottom line, are reluctant to give them up. As a result, insiders have resigned themselves to the belief that significant pharmacogenomics-driven regulatory breakthroughs are at least 10 years away.

Get the full story with
GenomeWeb Premium

Only $95 for the
first 90 days*

A trial upgrade to GenomeWeb Premium gives you full site access, interest-based email alerts, access to archives, and more. Never miss another important industry story.

Try GenomeWeb Premium now.

Already a GenomeWeb Premium member? Login Now.
Or, See if your institution qualifies for premium access.

*Before your trial expires, we’ll put together a custom quote with your long-term premium options.

Not ready for premium?

Register for Free Content
You can still register for access to our free content.

Precision medicine has to consider context in addition to genetic mutations in cancer treatment, Medscape reports.

Genomics may help the Cavendish banana from succumbing to fungal infections, a trio of researchers writes at the Conversation.

In PNAS this week: miR-515 levels higher in women with preeclampsia, horizontal gene transfer in parasitic plants, and more.

A cancer researcher retracts 19 articles from one journal for image manipulation, according to Retraction Watch.