1. In Vivo
  2. >>Archive

Pharmacogenomic Data and Labeling: A Less-Safe Harbor for Existing Drugs?

At the same time that FDA is taking pains to assure companies that pharmacogenomics data won't affect the review process for new drugs unless the agency and the sponsor first agree on the meaning of those data, it's also thinking of taking a tougher position with existing drugs.

At the same time that the FDA is taking pains to assure companies that pharmacogenomics data won't affect the review process for new drugs unless the agency and the sponsor first agree on the meaning of those data, it's thinking of taking a tougher position with existing drugs. The FDA is in the midst of considering the appropriate standards for reviewing labels of existing drugs to see if they should now include pharmacogenomics data that would better inform physician prescribing decisions. And the agency appears to be contemplating a threshold for review that is lower than the level of adverse event reporting that would trigger a review for the purposes of recalling a compound.

For some time, FDA officials have been ratcheting up efforts to work with industry to determine the appropriate uses for...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on In Vivo for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Archive

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Eleanor Malone

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Early Development Deals: Ipsen's Strategy For Biomarker-Driven Success

 
• By Eliza Slawther

Mary Jane Hinrichs, Ipsen’s head of early development, talks to In Vivo about getting ahead of the competition by securing deals for candidates before they enter Phase I trials.   

Shape Our Content: Take The Reader Survey

 
• By Eleanor Malone

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access In Vivo, or if you love it how it is, now is the time to have your voice heard.

Sponsored by:

Prioritizing Safety in CAR-T Therapy: Patient Monitoring with Cerba Research’s Testing Portfolio

The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.

More from In Vivo

The Rise In China Deals: How International Biopharma Is Turning To China For Innovation

 
• By Joseph Haas, Mary Jo Laffler, and Nancy Pham

The rapid growth of Chinese biopharmas has led to increased dealmaking with the US and Europe, but that could be stifled by a potential new Trump Administration policy.

Deals In Depth: August 2025

 
• By Deanna Kamienski and Maureen Riordan

Seven $1bn+ alliances were penned in August, and two exceeded $2bn.

As Pricing Pressures Mount, Biopharma Turns To AI To Reduce Trial Failure Rates

 
• By David Wild

With drug pricing policies potentially squeezing industry margins, companies are increasingly turning to AI-driven trial optimization to rescue sub-optimal studies and accelerate development timelines.