1. Pink Sheet
  2. >>Geography
  3. >>North America
  4. >>United States

FDA Sees Challenge In Distinguishing Lung Cancer Symptoms From Drug Side Effects

 
• By Sue Sutter

At the third patient-focused drug development meeting under PDUFA V, FDA staff urged patients to try to differentiate between symptoms caused by the underlying disease and those resulting from treatment, an important distinction when it comes to assessing the efficacy and safety of new drugs.

FDA’s patient-focused drug development public meeting on lung cancer showed the challenges of developing new outcome measures and clinical trial endpoints when the line between the disease’s symptom burden and the treatment’s side effects is blurred.

During the course of the half-day meeting June 28, it became clear that with lung cancer it can be difficult...

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 United States

ACIP ‘Pivot’ May Mean Variable US Coverage For New Vaccines, Higher Copays

 
• By Cathy Kelly

Clarity on payer responses to controversial vaccine recommendations from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices may be coming.

CAR-T Therapy Trials Involving Chinese Labs Will Face Heightened US FDA Scrutiny

 
• By Michael McCaughan

The FDA wants to ensure participants in clinical trials involving genetic engineering done in China understand what the agency sees as privacy and security risks. The agency also wants cell therapy processing done outside of “hostile” countries.

New CDER Deputy Director Michael Davis Brings Psychedelic Drug Development Experience

 
• By Sue Sutter

Davis, a former FDA team leader in the Division of Psychiatry Products, rejoins the agency from the Usona Institute, which develops psychedelics. His background aligns with Commissioner Martin Makary’s goal of seeing new treatments approved for post-traumatic stress disorder.

Crosstalk On Drug Pricing: Conflicts In Trump Team Rhetoric And Policy

 
• By Michael McCaughan

The Trump Administration’s rhetoric and policy approaches illustrate the confusion that often arises between efforts to cut drug prices and cutting spending.

More from North America