1. Pink Sheet
  2. >>R&D
  3. >>Clinical Trials

Drug Development Tool Qualification: US FDA Offers Three-Step Review Process

 
• By Brenda Sandburg

FDA's proposed review timeline to qualify biomarkers, clinical outcome assessments, and animal models can actually be pretty quick – assuming submissions clear the initial "reviewability" hurdle. 

Big medical set including equipment , medical tools and drugs. Vector hand drawn medical collection - Vector

The US FDA has set up a three-step review process to qualify tools for use in drug development. But before beginning this procedure, the agency first determines the "reviewability" of a sponsor's submission.

FDA officials described how the agency is implementing the new qualification process for drug development tools, established by the 21st...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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 Clinical Trials

Speed, Reach And Impact: New Metrics To Drive EU Clinical Trials Reform

 
• By Vibha Sharma

Clinical trials in the EU will be measured against new benchmarks from 2026 to identify how the bloc’s clinical research environment compares with that of other regions, and to identify areas for improvement.

HHS Long COVID Initiative Will Focus On ‘Front Line’ Approach To Treatment

 
• By Cathy Kelly

A project to advance effective treatments for long COVID was framed as a high priority for HHS Secretary Robert F. Kennedy Jr.

Do Policy, Clinical Data, Ocaliva Exit Lend Zydus Helping Hands?

 
• By Vibha Ravi

Intercept’s Ocaliva withdrawal in the US places the spotlight on emerging PBC candidates like Zydus’s saroglitazar, a PPAR agonist that beat both Gilead’s Livdelzi and Ipsen’s Iqirvo on biochemical response in topline results. Will the withdrawal and policy developments boost Zydus’s prospects?

Blueprint For RWE: Aetion Execs Outline Real-World Data Role From Preclinical To Postmarketing

 
• By Bridget Silverman

Sponsors should systematically incorporate real-world evidence generation in all development programs, advises an epidemiology-forward “blueprint” Aetion executives developed.

More from R&D

Blueprint For RWE: Aetion Execs Outline Real-World Data Role From Preclinical To Postmarketing

 
• By Bridget Silverman

Sponsors should systematically incorporate real-world evidence generation in all development programs, advises an epidemiology-forward “blueprint” Aetion executives developed.

Clawbacks And Clinical Trial Set Up Are Among UK’s Investment Deterrents

 
• By Francesca Bruce

In the wake of MSD’s decision not to invest $1.35bn in the UK, the Association of the British Pharmaceutical Industry has set out the county’s comparative strengths and weaknesses.

Merck & Co. Withdrawal Seen As Warning Of UK’s Declining Attractiveness

 
• By Andrew McConaghie

The decision to terminate discovery research was influenced by the US company’s cost-cutting measures but also discontent over the UK’s punitive clawback of revenues.